Senior Director, Regulatory Affairs

Role: Senior Director of Regulatory Affairs, overseeing U.S. regulatory strategy and FDA engagement for BeOne’s development and marketed oncology products. Responsibilities include developing integrated U.S. regulatory plans across clinical development, registration, and lifecycle management; leading FDA negotiations; ensuring regulatory compliance in filings like INDs, NDAs, and BLAs; and providing strategic advice to global teams. The role involves risk assessment, policy evaluation, and shaping regulatory practices, with a focus on oncology (both small molecule and biologics) and early to late-stage development. The individual will manage regulatory issues, influence portfolio decisions, and lead or contribute to departmental initiatives to enhance compliance, efficiency, and inspection readiness. Collaboration spans Clinical Development, Medical, Safety, Biostatistics, CMC, Quality, Legal, and Commercial functions, with significant external engagement and industry representation. Leadership includes talent development, organizational planning, and regulatory standards. The position offers extensive supervisory responsibilities for regulatory professionals. Qualifications include 15+ years in pharma/biotech, with proven leadership in U.S. regulatory strategy, FDA interactions, and complex program management, especially within oncology. Advanced scientific or regulatory degrees are preferred, alongside expertise in INDs, NDAs, expedited programs, and a track record of regulatory accomplishments. Travel is estimated at 10-20%. The role demands strong strategic, negotiation, and communication skills, with a focus on cross-functional collaboration and regulatory risk management.