GVP, Global Regulatory Affairs

Kiniksa Pharmaceuticals•Lexington, MA

4d•Onsite

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. As the organization’s senior regulatory leader, this person advises executive leadership and cross-functional development teams on portfolio strategy, development pathways, regulatory risks, and opportunities to accelerate programs while maintaining scientific and regulatory rigor. The GVP leads global regulatory strategy for early- and late-stage biologic programs and approved products, including Health Authority interactions, global submissions, registrations, and lifecycle strategies. The role contributes regulatory insight to evaluation and due diligence of new therapeutic opportunities and leads and develops the Global Regulatory Affairs organization, including oversight of Global Medical Safety. The GVP partners across Clinical Development, Medical, Safety, CMC, Commercial, Legal, and other functions, and represents the company before FDA, EMA, and other global Health Authorities. The role is based in Kiniksa’s Lexington, Massachusetts office and requires onsite work 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, such as PharmD, PhD, or MS.
15+ years of progressive Regulatory Affairs experience in 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 pathways with clinical development plans and corporate objectives.
Advise executive leadership on regulatory opportunities, precedent, risk, and implications for portfolio and investment decisions.
Shape regulatory strategy for early- and late-stage programs, identifying opportunities to accelerate development and optimize pathways to approval.
Provide regulatory leadership in evaluating new therapeutic opportunities, including due diligence and assessment of development pathways and risks.
Lead strategy for approved products, including global registrations, labeling, lifecycle management, and expansion opportunities.
Lead company 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 Health Authorities.
Provide senior leadership for major regulatory submissions, including BLAs, NDAs, MAAs, and significant post-approval filings.
Integrate regulatory strategy into clinical, CMC, safety, and commercial decision-making across cross-functional development teams.
Contribute 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 while 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.