GVP, Global Regulatory Affairs

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

Pay Range$360,000—$410,000 USDKiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.