GVP, Global Regulatory Affairs
About The Position
The Group Vice President, Global Regulatory Affairs provides enterprise-level regulatory leadership across Kiniksa’s development and commercial portfolio, shaping global regulatory strategy from early development through approval and lifecycle management. The role serves as a strategic advisor to executive leadership and cross-functional development teams on portfolio strategy, development pathways, regulatory risk, and opportunities to accelerate programs while upholding scientific and regulatory rigor. The GVP leads global regulatory strategy for early- and late-stage biologic programs and approved products, including pivotal Health Authority interactions, global submissions, registrations, and lifecycle strategies. The position also provides regulatory insight for evaluating new therapeutic opportunities and due diligence. The role leads and develops the Global Regulatory Affairs organization and oversees Global Medical Safety, building partnerships across Clinical Development, Medical, Safety, CMC, Commercial, Legal, and other functions. The GVP represents the company with FDA, EMA, and other Health Authorities worldwide. This position is based in the Lexington, Massachusetts office and requires employees to work onsite five days per week. Significant collaboration is required with core functions in the United States and Europe.
Requirements
- Advanced degree in a relevant scientific, medical, or pharmaceutical discipline (PharmD, PhD, or MS).
- 15+ years of progressive Regulatory Affairs experience within the biopharmaceutical industry, including significant senior-level regulatory leadership experience.
- Proven track record developing and executing U.S. and global regulatory strategies across multiple stages of drug development.
- Successful leadership of BLA and/or NDA submissions and approvals.
- Extensive experience leading interactions with FDA and other global Health Authorities.
- Deep knowledge of global drug development and regulatory requirements, including FDA, EMA, ICH, and global registration pathways.
- Demonstrated ability to provide strategic regulatory counsel to senior leadership and influence complex cross-functional development and portfolio decisions.
- Proven ability to build, lead, and develop high-performing regulatory teams.
Nice To Haves
- MAA and broader global registration experience.
- Experience with autoimmune, orphan, and/or expedited development programs.
- Regulatory CMC strategy and leadership experience.
- Experience leveraging AI or emerging technologies within Regulatory Affairs.
Responsibilities
- Define and lead U.S. and global regulatory strategies across development-stage and commercial programs, aligning regulatory pathways with clinical development plans and corporate objectives.
- Advise executive leadership on regulatory opportunities, precedent, risks, and implications for portfolio and investment decisions.
- Shape regulatory strategies for early- and late-stage development programs, identifying opportunities to accelerate development and optimize pathways to approval.
- Provide regulatory leadership in evaluating new therapeutic opportunities, including regulatory due diligence and assessment of development pathways and risks.
- Lead regulatory strategy for approved products, including global registrations, labeling strategy, lifecycle management, and expansion opportunities.
- Lead the company’s strategy and engagement with FDA, EMA, and other global Health Authorities, including high-impact interactions, negotiations, and milestone meetings.
- Establish regulatory positions and prepare the organization to communicate clear, scientifically grounded strategies to global Health Authorities.
- Provide senior leadership for major regulatory submissions, including BLAs, NDAs, MAAs, and significant post-approval filings.
- Serve as the senior regulatory leader across cross-functional development teams and integrate regulatory strategy into clinical, CMC, safety, and commercial decision-making.
- Contribute strategic regulatory input to clinical development plans, including indication strategy, evidence requirements, endpoint considerations, development sequencing, and registration planning.
- Partner with Clinical Development, Medical, Global Medical Safety, CMC, Commercial, Legal, and other functions to drive timely portfolio decisions.
- Lead, develop, and scale a high-performing Global Regulatory Affairs organization.
- Provide leadership and oversight to the Global Medical Safety function.
- Develop regulatory talent and succession capability, fostering accountability, collaboration, urgency, and sound judgment.
- Establish and maintain regulatory governance, policies, standards, and operating practices that support organizational growth and inspection readiness.
- Ensure compliance with applicable FDA, EMA, ICH, and global regulatory requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
