Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis. Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders. At Kiniksa, talented individuals are trusted and empowered to make a real impact—shaping the future of medicine while improving the lives of patients who need it most.

The Group Vice President, Global Regulatory Affairs will provide enterprise-level regulatory leadership across the company’s development and commercial portfolio, shaping global regulatory strategy from early development through approval and lifecycle management.

As the senior leader within the organization, this individual will serve as a strategic advisor to executive leadership and cross-functional development teams, providing regulatory perspective on portfolio strategy, development pathways, regulatory risk, and opportunities to accelerate programs while maintaining the highest standards of scientific and regulatory rigor.

The GVP will lead global regulatory strategy for early- and late-stage biologic programs and approved products, including pivotal Health Authority interactions, global submissions, registrations, and lifecycle strategies. This leader will also bring regulatory insight to the evaluation of new therapeutic opportunities and due diligence, helping inform investment and development decisions across the portfolio.

The individual will lead and further develop the Global Regulatory Affairs organization, including oversight of Global Medical Safety, and will establish strong partnerships across Clinical Development, Medical, Safety, CMC, Commercial, Legal, and other key functions. The role will represent the company with FDA, EMA, and other Health Authorities globally.

This role is based in our Lexington, MA office and requires employees to be onsite five days per week. Significant collaboration will be required with all core functions in the USA and Europe

Responsibilities (including, but not limited to):

Global Regulatory & Portfolio Strategy

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.
Serve as a senior regulatory advisor to executive leadership, providing clear perspective on regulatory opportunities, precedent, risk, and implications for portfolio and investment decisions.
Shape regulatory strategy for early- and late-stage development programs, identifying opportunities to accelerate development and optimize pathways to approval.
Provide regulatory leadership in the evaluation of 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.

Health Authority Leadership

Lead the company’s strategy and engagement with FDA, EMA, and other Health Authorities worldwide, including high-impact regulatory interactions, negotiations, and milestone meetings.
Establish regulatory positions and ensure the organization is prepared 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.

Development & Cross-Functional Leadership

Serve as the senior regulatory leader across cross-functional development teams, ensuring regulatory strategy is integrated into clinical, CMC, safety, and commercial decision-making.