Director, 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 Director, Regulatory Affairs, reports to the Executive Director, Regulatory Affairs and Writing (US based) and provides strategic regulatory leadership for drug development and commercial project(s)/program(s). This role supports US and/or outside-US (OUS) regulatory submissions and health authority interactions and develops strategies to reduce risk and identify opportunities to accelerate development in line with corporate objectives and timelines. The Director combines strategic leadership with hands-on support across early- and late-stage
