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About Hello Heart:

Hello Heart is on a mission to make heart attacks a thing of the past.

We’re an AI company focused exclusively on heart health, building a platform that predicts and prevents cardiac events before they happen—identifying risk up to 10 days in advance versus 10 years in traditional clinical models.

This is already working at scale. Hello Heart has been shown to reduce inpatient hospital days by 47% and deliver ~$1,800 in annual savings per member. Hello Heart is the cardiac prevention partner to over 80% of large U.S. health plans and serves hundreds of public and private employers.

We’re defining how the #1 cause of death—heart disease—is managed in the AI era. Join us.

As Associate General Counsel, Commercial, you’ll report directly to the General Counsel, providing commercially-minded strategic and scalable solutions to legal issues.  We need an innovative, collaborative, and organized partner who can help us identify and resolve complex issues in a user-focused, fast-paced environment. You’ll wear many hats – from reviewing contracts with health plans, partners, and vendors, to developing and managing systems and processes that drive efficiency and compliance, to handling the emerging needs of a growing company.

Responsibilities:

• Provide leadership and support across a wide variety of legal and business needs at a rapidly growing, dynamic startup
• Partner with internal stakeholders to build efficient processes for the commercial and compliance functions, including through the creation and maintenance of playbooks, templates, self-help workflows, and document management systems
• Negotiate a variety of agreements in the technology, digital health, and healthcare space, including partnership agreements, data agreements, MSAs, BAAs, and technology licensing agreements
• Undertake special projects and investigations to enable new business growth
• Become a trusted, go-to legal advisor who advances the company’s overall mission and goals while identifying and mitigating legal risks among a distributed workforce
• Remain up-to-date on relevant industry trends, laws and regulations to ensure an ongoing ability to provide sound compliance advice
• Responsibly manage outside counsel

Qualifications:

• 7+ years of commercial/technology/IP transactional or regulatory experience, including experience in a premier law firm setting. Experience in-house in healthcare, medical devices, or digital health preferred.
• Highly organized, strong project management skills, with the ability to handle multiple matters simultaneously in an entrepreneurial, dynamic environment
• Experience drafting and negotiating legal documents of varying levels of complexity
• Solid judgment in identifying key risks, finding elegant solutions, and working with business colleagues to appropriately mitigate risk to achieve the organization’s commercial goals
• Significant exposure to key regulatory and contractual issues in the digital health space, such as HIPAA, FDA, FTC, healthcare compliance, and intellectual property
• Team player, willing and able to pitch in across wide variety of legal and business needs, where no job is too big or too small
• Growth-minded with demonstrated ability to rapidly absorb and internalize new information and processes
• Excited to help conceptualize and build key capabilities and processes at rapidly growing startup
• Excellent oral and written communication skills, effective in a distributed environment
• JD from accredited U.S. law school; licensed in good standing with a state bar

The US base salary range for this full-time position is $230,000.00 to $270,000.00. Salary ranges are determined by role and level. Compensation is determined by additional factors, including job-related skills, experience, and relevant education or training. Please note that the compensation details listed in US role postings reflect the annual salary and bonus only, and do not include equity or benefits.

Hello Heart has a positive, diverse, and supportive culture - we look for people who are collaborative, creative, and courageous. Oh, and if you want to see some recent evidence of the fun things we do at Hello Heart, check out our Instagram page.

The Legal, Compliance, and Corporate Affairs (LCCA) team is seeking an Assistant General Counsel to lead key corporate governance and transactional matters and provide practical advice, guidance, and oversight on labor & employment and litigation matters in a fast-paced, high-energy environment. This is a fiduciary role that supports GHX’s compliance with relevant laws and regulations. The Assistant General Counsel will monitor and advise on trends in business performance, evolving regulatory requirements, and best practices for governance and disclosure. The individual in this role will work closely with senior leadership and key leaders in the LCCA to manage corporate governance and entity matters; draft, negotiate, and maintain corporate documents and agreements; oversee labor & employment and litigation matters and outside counsel as appropriate; identify and resolve legal issues; and develop efficient legal processes, all while balancing legal and business needs and risks. The ideal candidate is a versatile in-house leader who is open to working across a wide array of legal matters. The Assistant General Counsel will have the opportunity to work as a corporate generalist, assume meaningful responsibility for key legal matters, and build on an array of critical corporate legal department skills.

Principal Duties and Responsibilities:

• Reporting directly to the General Counsel & Corporate Secretary, you will serve as a trusted adviser on a range of corporate legal matters, including corporate governance.
• Lead and support corporate governance matters, including preparation and organization of materials for Board and Committee meetings, maintenance of corporate records, entity management for GHX’s North American and India entities, corporate disclosure materials, and related regulatory matters.
• Manage the preparation, review, and maintenance of corporate records, organizational documents, approvals, resolutions, subsidiary records, and other governance materials.
• Advise on the Company’s corporate financing matters, debt-related reporting obligations, transaction documentation, and related corporate approvals.
• Support and, as appropriate, lead corporate transactions, including mergers and acquisitions, financings, liquidity events, and other strategic transactions, from structuring and due diligence through execution and post-closing integration.
• Lead and support complex commercial transactions with strategic partners and other key counterparties, including structuring, negotiation, drafting, execution, and ongoing relationship management.
• Support the management of ESG-related legal and disclosure matters and assist the team in the continued development of GHX’s ESG program.
• Draft, negotiate and interpret non-disclosure agreements (NDAs), letters of intent (LOIs), and other corporate agreements.
• Support subsidiary management of corporate affiliates.
• Provide practical advice and guidance on labor & employment and litigation matters, manage internal legal workstreams, and oversee outside counsel as appropriate.
• Manage GHX’s insurance portfolio, including coordination of renewals, coverage analysis, claims support, and engagement with brokers, insurers, and internal stakeholders.
• Coordinate with outside counsel as needed across corporate, transactional, labor & employment, litigation, and other legal matters.
• Support the General Counsel & Corporate Secretary on other corporate matters as needed, including risk management, corporate development, and other strategic initiatives.
• Provide legal support for ad-hoc projects coming from various departments, including Treasury and Accounting.
• Willingness to travel quarterly (up to 20% annually).

Required Qualifications:

• J.D. required.
• Admission to, and in good standing in, any state bar in the United States.
• At least 7 years of legal experience, including substantial experience in corporate governance and corporate transactions. Experience in a law firm, in-house legal department, or both is preferred.
• Excellent analytical, interpersonal, and presentation skills.
• Ability to communicate effectively in writing and in person to all levels of the business, including senior management.
• Ability to be nimble and adaptable to a variety of legal questions and concerns.
• A high-integrity, low-ego team player who takes a collaborative approach to problem solving, enjoys working as part of a close-knit team, and takes ownership of matters with appropriate autonomy.
• Hard working, well organized, self-motivated, and able to work independently.
• Ability to manage and prioritize requests and oversee and improve complex business and legal processes under time pressures and deadlines in a fast-paced environment.
• Excellent academic credentials.

Preferred Qualifications:

• Experience working in or advising private equity-backed companies is preferred.
• Prior in-house, corporate legal department experience.
• Experience supporting or leading mergers and acquisitions, financings, and other strategic corporate transactions, including transaction structuring, due diligence, documentation, execution, and integration.
• Experience advising on labor & employment matters and overseeing litigation, including management of outside counsel, is preferred.
• Exposure to intellectual property, marketing and advertising, or related technology matters is a plus.
• Experience with technology transactions, SaaS businesses, or delivery of SaaS products is a plus.
• Executive compensation experience.

Estimated salary range: $150,000 - $214,000

The base salary range represents the anticipated low and high end of the GHX’s salary range for this position. Actual salaries will vary and will be based on various factors, such as candidate’s qualifications, skills, competencies and proficiency for the role. The base salary is one component of GHX’s total compensation package for employees. Other rewards and benefits include: health, vision, and dental insurance, accident and life insurance, 401k matching, paid-time off, and education reimbursement, to name a few. To view more details of our benefits, visit us here: https://www.ghx.com/about/careers/

#LI-Remote #LI-KL

GHX: It’s the way you do business in healthcare

Global Healthcare Exchange (GHX) enables better patient care and billions in savings for the healthcare community by maximizing automation, efficiency and accuracy of business processes.

GHX is a healthcare business and data automation company, empowering healthcare organizations to enable better patient care and maximize industry savings using our world class cloud-based supply chain technology exchange platform, solutions, analytics and services. We bring together healthcare providers and manufacturers and distributors in North America and Europe - who rely on smart, secure healthcare-focused technology and comprehensive data to automate their business processes and make more informed decisions.

It is our passion and vision for a more operationally efficient healthcare supply chain, helping organizations reduce - not shift - the cost of doing business, paving the way to delivering patient care more effectively. Together we take more than a billion dollars out of the cost of delivering healthcare every year. GHX is privately owned, operates in the United States, Canada and Europe, and employs more than 1000 people worldwide. Our corporate headquarters is in Colorado, with additional offices in Europe.

Disclaimer

Global Healthcare Exchange, LLC and its North American subsidiaries (collectively, “GHX”) provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, national origin, sex, sexual orientation, gender identity, religion, age, genetic information, disability, veteran status or any other status protected by applicable law. All qualified applicants will receive consideration for employment without regard to any status protected by applicable law. This EEO policy applies to all terms, conditions, and privileges of employment, including hiring, training and development, promotion, transfer, compensation, benefits, educational assistance, termination, layoffs, social and recreational programs, and retirement. GHX believes that employees should be provided with a working environment which enables each employee to be productive and to work to the best of his or her ability. We do not condone or tolerate an atmosphere of intimidation or harassment based on race, color, national origin, sex, sexual orientation, gender identity, religion, age, genetic information, disability, veteran status or any other status protected by applicable law. GHX expects and requires the cooperation of all employees in maintaining a discrimination and harassment-free atmosphere. Improper interference with the ability of GHX’s employees to perform their expected job duties is absolutely not tolerated.

Read our GHX Privacy Policy

AHCCCSArizona Health Care Cost Containment System Accountability, Community, Innovation, Leadership, Passion, Quality, Respect, Courage, Teamwork The Arizona Health Care Cost Containment System (AHCCCS), Arizona’s Medicaid agency, is driven by its mission to deliver comprehensive, cost-effective health care to Arizonans in need.

The role

Gauntlet is hiring its first dedicated Head of Compliance. Compliance responsibilities currently sit across Legal and the wider business. This role brings that work together, identifies the gaps, and establishes a clear, practical program that scales with the company.

Reporting to the General Counsel, you will set the direction but also own the execution: writing the policies, building the processes, implementing the tooling, and running the monitoring to make sure the program works in practice.

Gauntlet recently completed its Series C and as the business grows we need a compliance program that keeps pace without creating unnecessary friction. The scope is broad - financial crime, securities regulation, privacy, marketing, employment, anti-corruption, regulatory registrations, and other areas that emerge as the business develops.

This is a hands-on senior role with meaningful ownership, direct access to company leadership, and the chance to build a program suited to an onchain financial business rather than inherit one designed for a different kind of company.

About Gauntlet

Gauntlet builds the financial systems of the future. While much of on-chain finance is focused on point solutions, we operate across the entire stack to offer best-in-class vault products. Today, we serve over $1.6B in client TVL across some of the largest fintechs/neobanks, protocols, exchanges, and capital allocators in crypto, and, increasingly, traditional asset management. Our team brings together traditional finance and crypto-native expertise to deliver durable, sophisticated products for institutional clients moving on-chain

What you’ll do;

• Build and run Gauntlet’s compliance program, including its priorities, governance, controls, and operating cadence.
• Draft, update, and implement policies and procedures across the business, and establish a practical compliance testing and monitoring program.
• Create reporting, escalation, and governance processes that give leadership a clear view of compliance risks and issues.
• Support upcoming registrations, help prepare the business for the regulatory requirements that follow, and coordinate regulatory examinations, audits, and related information requests.
• Partner with Legal, Product, Engineering, Finance, People, and commercial teams to incorporate compliance requirements into their day-to-day work, and review and improve company-wide compliance training.
• Advise the business across financial crime, privacy, marketing, securities, anti-corruption, employment, and other relevant areas.
• Use AI and automation to make monitoring, reporting, policy management, and other compliance workflows more efficient.
• Keep the program current as Gauntlet’s products, clients, and regulatory obligations evolve.

What success looks like;

First 30 days. Map the compliance work already happening across Legal and the wider business. Meet stakeholders across Product, Engineering, Finance, People, and commercial teams. Form a clear view of the gaps and a prioritized plan for closing them.

First 3–6 months. Core policies and procedures drafted and rolling out. A practical testing and monitoring program stood up. Reporting, escalation, and governance cadence running, giving leadership a clear view of compliance risk. Registration preparation on track.

In 1 year. A compliance program that scales with the business: registrations supported, examinations and audits running smoothly, and teams involving compliance early — not only after a problem has occurred. The program manages risk practically, without unnecessary friction.

What you bring

• Experience building a compliance program, standing up a major part of one, or materially improving how an existing program operates.
• Broad compliance experience across several domains rather than a single speciality, with strong knowledge of how policies, controls, monitoring, testing, training, reporting, and governance work together.
• Experience supporting regulatory registrations, examinations, audits, or similar engagements.
• A willingness to work directly on the detail — you can both set the approach and execute it, without needing a mature compliance function around you to get started.
• The ability to give clear, practical guidance without overcomplicating it: managing risk pragmatically rather than defaulting to the most conservative answer, while giving a clear “no” when the risk requires it.
• Good judgement and the confidence to raise concerns directly when something does not look right.
• Comfort working in a growing company where the priorities and regulatory questions will continue to evolve.

Bonus points

• Experience in crypto, digital assets, or onchain financial products, and familiarity with the regulatory questions facing businesses operating across traditional and onchain finance.
• A compliance designation such as CAMS, CRCM, or CCEP.
• Existing experience working with relevant regulators.
• Experience using AI, automation, or data tooling within a compliance program.

Benefits and Perks

• Remote first - work from anywhere in the US & CAN!
• Regular in-person company retreats and cross-country “office visit” perk
• 100% paid medical, dental, and vision premiums for employees
• $1,000 WFH stipend
• Monthly reimbursement for home internet, phone, and cellular data
• Unlimited vacation
• 100% paid parental leave of 12 weeks
• Fertility benefits
• Opportunity for incentive compensation

The national pay range for this role is $200,000 - $240,000 base plus additional On Target Earnings potential by level and equity in the company. Our salary ranges are based on paying competitively for a company of our size and industry, and are one part of many compensation, benefits and other reward opportunities we provide. Individual pay rate decisions are based on a number of factors, including qualifications for the role, experience level, skill set, and balancing internal equity relative to peers at the company.

#LI-Remote

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

About the jobMercor connects elite creative and technical talent with leading AI research labs.

About the jobMercor connects elite creative and technical talent with leading AI research labs.

We are currently seeking a Legal Consultant with Structured Products/ Global Markets experience to join us and support our global banking client offering a collegiate and supportive environmentResponsibilities: Provide legal support...

We are currently seeking a Legal Consultant with experience in Cryptocurrency / Digital Payment to support our global fintech client:Responsibilities: Lead regulatory strategy for stablecoin / digital payment / asset...

HackerOne is a global leader in Continuous Threat Exposure Management (CTEM). The HackerOne Platform unites agentic AI solutions with the ingenuity of the world’s largest community of security researchers to...

Chainguard is the trusted source for open source. By delivering hardened, secure, and production-ready builds of all the open source software engineers and AI agents rely on, Chainguard helps organizations build faster, stay compliant, and eliminate risk.

Our customers include Fortune 500 enterprises and global industry leaders, including Anduril, Canva, Fortinet, Hewlett Packard Enterprise, OpenAI, Snap Inc., and Snowflake.

Chainguard is venture-backed by leading investors, including Amplify, IVP, Kleiner Perkins, Lightspeed Venture Partners, Mantis VC, Redpoint Ventures, Sequoia Capital, and Spark Capital.

The role, in a nutshell:

We’re looking for our first IP/Product Counsel to help Chainguard protect, monetize, and scale what we’re building. Chainguard moves quickly. As a result, open source licensing questions, product launch nuances, and IP protection are part of the day-to-day business, not occasional legal requests.

This role sits at the intersection of IP and product. You’ll manage our growing IP portfolio, lead enforcement efforts when our licensing terms are violated, and work closely with product and engineering teams as they build and launch new products and features.

This is a role with a significant runway. We’re not looking for someone to walk in and build a fully staffed function on day one. We’re looking for someone who can take ownership, build scalable processes, and grow the function over time.

The ideal candidate has a strong background in IP law, particularly open source licensing, trademark and copyright, with patent  and technology transactions experience as a plus. You’ll also have experience working closely with product teams, including drafting product terms, reviewing terms of service, and advising on the relevant privacy, licensing, and IP implications of new products and features.

You should be comfortable working across both sides of IP: proactively building protections for the company and enforcing those protections when needed. Fluency in open source licensing is required, including knowledge of standard permissive and copyleft licenses (e.g., MIT, Apache 2.0, BSD, GPL, LGPL, MPL) and non-standard (e.g. dual license) , as you’ll work with engineering teams on open source questions on a regular basis.

What You’ll Do:

• Own and grow Chainguard’s international IP portfolio;
• Lead IP enforcement efforts, including cease-and-desist actions involving customers or competitors who violate our licensing terms;
• Serve as a go-to legal resource for open source licensing questions from engineering;
• Advise product teams on licensing, IP, and terms of service considerations across multiple concurrent product and feature launches;
• Draft and review product terms and terms of service for new launches;
• Advise on licensing considerations in partner and joint development agreements;
• Partner with product and engineering teams early in the development process to identify and address legal considerations before launch; and
• Build scalable IP processes, templates, and resources as the function grows

What We’re Looking For:

• 5+ years of legal experience with a strong foundation in IP law, including trademark and copyright; patent experience is a plus
• Strong knowledge of open source licensing is highly valued, as these questions come up regularly in the role
• Experience advising on product launches, product roadmaps, product terms, or terms of service is a plus, but not required
• Strong IP experience can outweigh lighter product counsel experience
• Comfort working both proactively to build and protect the company’s IP and reactively when enforcement is required
• This is an individual contributor role today with the opportunity to grow into leading the function over time

Why This Role:

Chainguard recently experienced the busiest product launch stretch in company history. The pace isn’t slowing down, and neither are the IP and licensing questions that come with it.

This role will sit at the center of that work. You’ll help build the protections around what we’re creating, handle disputes when they arise, and partner directly with product and engineering teams before they ship.

As Chainguard continues to scale, so will this function. For the right person, there’s a real opportunity to shape how we approach IP and product counsel and potentially build and lead a team over time.

Base Salary Range

$200,000—$225,000 USD

About Us

We live and breathe our company values:

• We are customer obsessed — We focus on delivering solutions to our customers that create value and make their lives better.
• We have a bias for intentional action — We prioritize, plan, try things, and fail fast.
• We don’t take ourselves too seriously (but we do serious work) — We are solving an important problem which takes focus, but we also like to enjoy the journey.
• We trust each other and assume good intentions — We’re transparent with decisions to empower team members to make well informed decisions.

A few of the benefits we offer:

• Flexible & Remote-First Culture: Work remotely with team meetup opportunities, bi-annual destination summits, and a monthly stipend for coworking spaces, phone and internet costs.
• Our Approach to Equity: Receive stock options upon hire and promotion. Plus, you can participate in secondary offerings and have 10 years to exercise your options (yes, you read that correctly: 10 years!).
• 100% Covered Health Insurance: We cover 100% of your health, vision and dental insurance premiums for you and your dependents. Nothing comes out of your paycheck.
• ∞ Flexible Time Off: Take the time you need – to do our best work, we need to recharge and reset.
• 18 Weeks Paid Parental Leave: We offer 18 weeks for birthing parents and 12 weeks for non-birthing parents, with the option to use it all at once or throughout your child’s first year.

If your experience is close but doesn’t fulfill all requirements, please apply. We’re building the best team in technology and are focused on hiring “Chainguardians” with unique backgrounds, perspectives, and experiences.

Chainguard is an equal opportunity employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, reproductive health decisions, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetic information, political views or activity, or other applicable legally protected characteristics. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law.

By submitting your application, you acknowledge that Chainguard will process your personal data in accordance with Chainguard’s Global Candidate Privacy Notice.

©2026 Chainguard. All Rights Reserved.

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.

Title: Executive Director, Medical Writing

Reports to: Chief Regulatory Officer

Location: Emeryville (Hybrid) OR Remote (West coast hours preferred)

Position Summary

The Executive Director, Medical Writing serves as the functional lead for Medical Writing, providing strategic and operational leadership across the full product lifecycle. This role is responsible for establishing the vision, operating model, and capabilities of the Medical Writing function while ensuring the delivery of high-quality, scientifically rigorous, and submission-ready documentation that supports Kyverna’s development, regulatory, and commercialization objectives.

As a key member of the Regulatory leadership team, the Executive Director partners closely with Regulatory Affairs, Clinical Development, Clinical Operations, Biometrics, Medical Affairs, Pharmacovigilance, Quality, and Program Leadership to translate portfolio priorities into effective medical writing strategies and execution plans. This individual influences functional and portfolio decisions through operational expertise, identifies and mitigates regulatory documentation risks, and builds organizational capabilities that enable successful global submissions and lifecycle management.

Responsibilities

• Lead the Medical Writing function, its strategic direction, operating model, and capabilities to support Kyverna’s evolving development portfolio.
• Develop departmental goals and operational priorities aligned with organizational objectives and Regulatory Affairs strategies.
• Serve as the functional representative on cross-functional governance and program teams, providing expert guidance on document strategy, planning, and execution.
• Build a high-performing organization capable of supporting clinical development, regulatory submissions, and commercialization.
• Provide executive oversight for the planning, development, review, and delivery of complex regulatory and scientific documents across all stages of product development and lifecycle management, including: Clinical study protocols, Investigator’s Brochures, Clinical Study Reports, INDs, BLAs, and other global regulatory submissions, Health Authority briefing packages and responses, Labeling support documents, Post-approval lifecycle management documentation, Safety and pharmacovigilance documentation, as applicable.
• Partner with Regulatory Affairs leadership to develop integrated document strategies that support global submission objectives.
• Provide scientific and regulatory guidance on complex content development, messaging, and submission readiness.
• Ensure all documents meet applicable regulatory requirements and company quality standards.
• Partner with senior leaders across Clinical Development, Regulatory Affairs, Biometrics, Clinical Operations, Medical Affairs, Pharmacovigilance, Quality, and Program Management to proactively identify documentation needs and execution risks.
• Influence cross-functional planning by providing operational insight into submission strategy, resource requirements, timelines, and regulatory deliverables.
• Lead resolution of complex issues affecting regulatory documentation quality, timelines, or submission readiness.
• Represent Medical Writing during regulatory inspections, due diligence activities, and partner interactions, as appropriate.
• Recruit, develop, and retain a high-performing Medical Writing organization.
• Establish organizational structure, workforce planning, and succession strategies that support business growth.
• Foster a culture of scientific excellence, accountability, collaboration, and continuous improvement.
• Coach and develop leaders within the function while establishing clear performance expectations and career development opportunities.
• Develop and oversee departmental processes, standards, templates, metrics, and governance to ensure consistent, efficient execution.
• Lead resource planning and capacity management across internal staff and external partners.
• Oversee departmental budget planning and vendor strategy, ensuring appropriate utilization of external medical writing resources.
• Drive continuous improvement initiatives that enhance quality, efficiency, scalability, and regulatory compliance.

Qualifications

• Advanced degree in life sciences, pharmacy, medicine, or related discipline (PhD, PharmD, MD, or equivalent preferred).
• 12+ years of progressive medical writing experience within the biotechnology or pharmaceutical industry, including significant leadership experience.
• Demonstrated success leading Medical Writing organizations supporting global clinical development and regulatory submissions.
• Deep understanding of global regulatory requirements and guidance (FDA, EMA, ICH) across the product lifecycle.
• Experience supporting major regulatory submissions, including INDs, BLAs, MAAs, and lifecycle management activities.
• Proven ability to influence cross-functional decision making and build collaborative relationships across senior leadership teams.
• Experience developing organizational capabilities, leading organizational change, and scaling teams within a growing company.
• Strong executive communication, leadership, and interpersonal skills.
• Demonstrated ability to manage multiple complex programs while balancing strategic priorities with operational execution.

The national salary range for this position is $275K to $300K USD annually.   The salary range is an estimate of what we reasonably expect to pay for this position, and the actual salary may vary based on various factors, including without limitation individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data.  This position is also eligible for bonus, benefits, and participation in Company’s stock plan.

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. They assure that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities:

• This individual has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL), in the development & execution of the regulatory strategy.  Area of responsibility has significant regulatory impact and possibly significant impact to AbbVie overall.
• Leads total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, addressing Health Authority information requests, annual reporting, and internal regulatory requests among others, providing business-critical decision and strategy support.
• Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel.  May also serve as primary liaison and interface with FDA for meetings, teleconferences and coordinates preparation of FDA meeting briefing packages and responses.
• Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
• Operates independently, with recognition of when to consult management.  Makes decisions and plans for operations (workflow, assignments) within area of responsibility with minimal direction.
• Coordinates, prepares and/or supervises the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.  Ensures application of established policies and best practice regulatory standards for all US/Canada product registrations.
• Demonstrates understanding of current US and Canada regulations and guidance, political and legal climate and industry practices to assist in meeting organizational goals.  Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Presents pertinent regulatory information to appropriate cross-functional teams.
• Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Minimum Qualifications:

• Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification
• 5+ years Regulatory, R&D, or equivalent industry-related experience.
• Experience in medical device space
• Experience with digital health/software
• Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience preferred).
• Experience working in a complex and matrix environment.
• Experience interfacing with government regulatory agencies.

Preferred Qualifications:

• Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities
• Global regulatory experience is a plus.

Other Required Skills:

• Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
• Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
• Able to deliver challenging messages effectively without compromising important business relationships.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. They assure that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities:

• This individual has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL), in the development & execution of the regulatory strategy.  Area of responsibility has significant regulatory impact and possibly significant impact to AbbVie overall.
• Leads total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, addressing Health Authority information requests, annual reporting, and internal regulatory requests among others, providing business-critical decision and strategy support.
• Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel.  May also serve as primary liaison and interface with FDA for meetings, teleconferences and coordinates preparation of FDA meeting briefing packages and responses.
• Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
• Operates independently, with recognition of when to consult management.  Makes decisions and plans for operations (workflow, assignments) within area of responsibility with minimal direction.
• Coordinates, prepares and/or supervises the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.  Ensures application of established policies and best practice regulatory standards for all US/Canada product registrations.
• Demonstrates understanding of current US and Canada regulations and guidance, political and legal climate and industry practices to assist in meeting organizational goals.  Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Presents pertinent regulatory information to appropriate cross-functional teams.
• Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Minimum Qualifications:

• Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification
• 5+ years Regulatory, R&D, or equivalent industry-related experience.
• Experience in medical device space
• Experience with digital health/software
• Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience preferred).
• Experience working in a complex and matrix environment.
• Experience interfacing with government regulatory agencies.

Preferred Qualifications:

• Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities
• Global regulatory experience is a plus.

Other Required Skills:

• Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
• Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
• Able to deliver challenging messages effectively without compromising important business relationships.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager, Regulatory Affairs US & Canada Strategy Lead – Aesthetics Device is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development. This individual demonstrates the ability to combine knowledge of scientific, regulatory & business issues to enable development and commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements. They assure that regulatory strategies defined within the Global Regulatory Product Team (GRPT), are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured, or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities:

• This individual has responsibility for products/multiple driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL), in the development & execution of the regulatory strategy.  Area of responsibility has significant regulatory impact and possibly significant impact to AbbVie overall.
• Leads total product lifecycle activities, including product/manufacturing change assessments, post-approval requirements, addressing Health Authority information requests, annual reporting, and internal regulatory requests among others, providing business-critical decision and strategy support.
• Manages interface with Health Authority (FDA) for key projects/issues, including direct collaboration with review division personnel.  May also serve as primary liaison and interface with FDA for meetings, teleconferences and coordinates preparation of FDA meeting briefing packages and responses.
• Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
• Operates independently, with recognition of when to consult management.  Makes decisions and plans for operations (workflow, assignments) within area of responsibility with minimal direction.
• Coordinates, prepares and/or supervises the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.  Ensures application of established policies and best practice regulatory standards for all US/Canada product registrations.
• Demonstrates understanding of current US and Canada regulations and guidance, political and legal climate and industry practices to assist in meeting organizational goals.  Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Presents pertinent regulatory information to appropriate cross-functional teams.
• Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Minimum Qualifications:

• Advanced degree (e.g. PharmD, PhD, MS) or Regulatory certification
• 5+ years Regulatory, R&D, or equivalent industry-related experience.
• Experience in medical device space
• Experience with digital health/software
• Proven skill at implementing successful affiliate regulatory strategies (US or Canada experience preferred).
• Experience working in a complex and matrix environment.
• Experience interfacing with government regulatory agencies.

Preferred Qualifications:

• Preferred: Advanced Degree and/or Certifications or direct experience with pharmaceutical regulatory activities
• Global regulatory experience is a plus.

Other Required Skills:

• Demonstrates excellent negotiation skills, problem solving skills and builds consensus.
• Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
• Able to deliver challenging messages effectively without compromising important business relationships.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our long-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Location: Fully remote in EuropeWorking Hours: Mon – Fri, 9AM – 6PM CETAbout Nivoda 🚀Nivoda is a rapidly scaling global B2B diamond and gemstone marketplace connecting jewellery retailers with competitive,...

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Associate, RA CMC is responsible for ensuring RA-CMC post approval change objectives are met by project managing marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents.  The Senior Associate will also ensure proper communication with all key partners in the functional departments in support of regulatory filings.

Responsibilities:

• Manage, compile, and author CMC sections of marketed product variations with minimal management oversight.  Update simple CMC documents independently.
• Partner with RA CMC Project Leads to create and develop content plans, bundling strategies, and project timelines.
• Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
• Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Independently run team review and management reviews of submission documents.
• Ensure CMC expectations including CTD content, structural and formatting requirements are being met for assigned projects.
• Provide input into and utilize current best practices for use of regulatory business systems within the group.
• Timely communication of systems issues to management.
• Communicate content gaps and risks for variation documents identified by RA CMC Project Leads.
• Provide guidance on use of submission document templates.
• Support annual reports and renewals (ad hoc baseline support)
• This role works a hybrid work schedule (3 days in office & 2 days remotely) from the Lake County, IL; Waltham, MA or Irvine, CA AbbVie headquarters.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

• Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
• Required Experience: 4 years pharmaceutical or industry related experience. 1-2 years in quality systems or cross functional project management
• Preferred Experience: 5 years pharmaceutical experience including 1-2 years in regulatory affairs or 1-2 years in Discovery, R&D, or Manufacturing
• Strong working knowledge of manufacturing unit operations or CTD structure
• Superior oral and written communication skills
• Ability to work cooperatively with all levels and types of global personnel required
• Experience working with electronic document management systems
• Ability to work independently under pressure and manage multiple projects simultaneously
• Detail/accuracy oriented
• Collaborative and willing to learn
• Familiarity with US and other international regulatory requirements for drug product dossiers

Additional Information

​Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our short-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of  any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development.

They assure that regulatory strategies defined within the GRPT, are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities:

• Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy.
• Assigned matters may have a moderate impact on business activities and operations.
• Serves as HA liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion of FDA meeting briefing packages and responses.
• Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
• Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.
• Assists in the development, training of staff members.
• Key contributor responsible for the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.
• Supports the regulatory submission and approval process.
• Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidances, as well as corporate policies and management-related considerations.
• Presents pertinent regulatory information to appropriate cross-functional areas.
• Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Minimum Qualifications:

• Bachelor’s degree (pharmacy, biology, chemistry, pharmacology or related)
• 6 years Regulatory, R&D, or Industry-related experience.
• Experience working in a complex and matrix environment.
• Experience interfacing with government regulatory agencies.

Preferred Qualifications:

• 2-3 years in pharmaceutical regulatory activities
• Global regulatory experience is a plus.
• Advanced Degree a plus
• Certifications a plus

Other Required Skills:

• Excellent negotiation skills, problem solving skills and builds consensus.
• Effective communication skills in written and oral channels both within Regulatory and across the organization.
• Able to deliver challenging messages effectively without compromising important business relationships.
• Proven skill at implementing successful US and Canada regulatory strategies regulatory strategies.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Company Description

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada (Hybrid) is responsible for the development and implementation of US and Canada regulatory strategic and tactical planning (RSTP) for assigned on market products or those products in development.

They assure that regulatory strategies defined within the GRPT, are effectively implemented and maintained in line with changing regulatory and business needs. This individual identifies and gathers data needed to support filings, responses to inquiries, and registration maintenance to enable commercialization of products that are developed, manufactured or distributed to meet relevant US and Canada regulatory requirements.

Responsibilities:

• Responsible for a product(s) or products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in the development & execution of the regulatory strategy.
• Assigned matters may have a moderate impact on business activities and operations.
• Serves as HA liaison and interfaces with FDA for meetings, teleconferences and coordinates preparation and completion of FDA meeting briefing packages and responses.
• Advise internal customers who may contribute to regulated communication on Regulatory/FDA issues including Public Affairs, Clinical Development, Legal, and others such as Commercial.
• Functions independently in negotiation and decision-making for project related issues that have cross-functional impact.
• Assists in the development, training of staff members.
• Key contributor responsible for the preparation and review of regulatory submissions consistent within US and Canada regulatory requirements and guidelines and assures complete and timely response to Health Authorities during application review.
• Supports the regulatory submission and approval process.
• Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
• Recommends and implements changes to difficult projects based on knowledge and expertise, accurate interpretation of US and Canada government regulations, guidances, as well as corporate policies and management-related considerations.
• Presents pertinent regulatory information to appropriate cross-functional areas.
• Operates in compliance with regulations, company policies, procedures, and guidance in alignment with regulatory product strategy and the Quality Dossier Program (QDP).

Qualifications

Minimum Qualifications:

• Bachelor’s degree (pharmacy, biology, chemistry, pharmacology or related)
• 6 years Regulatory, R&D, or Industry-related experience.
• Experience working in a complex and matrix environment.
• Experience interfacing with government regulatory agencies.

Preferred Qualifications:

• 2-3 years in pharmaceutical regulatory activities
• Global regulatory experience is a plus.
• Advanced Degree a plus
• Certifications a plus

Other Required Skills:

• Excellent negotiation skills, problem solving skills and builds consensus.
• Effective communication skills in written and oral channels both within Regulatory and across the organization.
• Able to deliver challenging messages effectively without compromising important business relationships.
• Proven skill at implementing successful US and Canada regulatory strategies regulatory strategies.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our long-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html