Director, Regulatory Affairs Labeling

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.

Reporting to the Executive Director, Regulatory Affairs AdPromo and Labeling, the Director, Regulatory Affairs Labeling, will be responsible for all labeling activities for approved products, as well as products in development that are nearing original submissions to the FDA and other health authorities. This role will also serve on the Promotional Review Committee (PRC) and the Medical Review Committee (MRC) for assigned activities. This individual will provide timely input to cross-functional teams responsible for reviewing labeling and promotional materials for Kiniksa’s products and will ensure effective communication with business partners and regulatory authorities.

This role is based in our Lexington, MA office and requires employees to be onsite five days per week.

Responsibilities (_including, but not limited to_):

• Lead cross-functional teams in the development and maintenance of labeling content, including USPI, SmPC, IFU, PPI, and CDS.
• Manage labeling development, review, and approval workflows, including related meetings, documents, ...

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.

Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium, totam rem aperiam, eaque ipsa quae ab illo inventore veritatis.