Associate Director Global Regulatory Sciences - Oncology

Associate Director, Global Regulatory Strategy, Hematology/Oncology We are seeking an experienced regulatory professional to lead global and U.S. regulatory activities for the Hematology/Oncology portfolio. The role will develop strategy, lead submissions, interact with regulators, and collaborate with cross‑functional teams. Responsibilities Develop global regulatory strategy across development and life‑cycle management, integrating guidance, commercial needs, and company objectives. Lead regulatory dossier submissions to global and FDA (IND, BLA, NDA, supplements). Manage quality controls to ensure compliant submissions. Work with cross‑functional groups to define and manage contributions to submissions. Write regulatory documents (INDs, briefing books, BT designations, priority review requests, ODD) and review core documents. Participate in rapid‑response teams to address CTA queries on new protocols and amendments. Lead or participate in regulatory interactions with FDA. Collaborate with the Global Regulatory Team to develop submission and Health Authority interaction plans. Use project‑management techniques, facilitate issue resolution, negotiate, and influence outcomes. Qualifications PhD, MD, Pharm.D. or BS/MS in regulatory science or related field. 4–8 years of pharmaceutical industry experience; 3–5 years in regulatory affairs. Thorough knowledge of IND and NDA processes and preparation of FDA submissions. Strong experience with U.S. regulatory submissions and dossiers (INDs, NDAs). Demonstrated leadership of cross‑functional teams and representation of regulatory functions. Ability to innovate, analyze, and solve problems with minimal supervision and attention to detail. Excellent communication, issue‑resolution, negotiation, and conflict‑management skills. Experience managing meetings and applying project‑management techniques. Some travel may be required. Compensation Overview Cambridge Crossing: $199,350 - $241,566 Princeton - NJ - US: $173,350 - $210,058 Starting compensation is based on required skills, location, and experience. Additional incentive cash and stock opportunities may be available. Benefits Summary Health coverage: medical, pharmacy, dental, and vision. Well‑being support: well‑being account, living life better programs, and employee assistance program. Financial well‑being: 401(k), disability, life and accident insurance, supplemental health, business travel protection, liability protection, identity‑theft benefit, legal support, and survivor support. Work‑life benefits: flexible time off (unlimited for exempt employees with manager approval), paid national holidays, paid vacation for non‑exempt employees, paid sick time, volunteer days, summer hours flexibility (US only), and annual global shutdown. Equal Employment Opportunity BMS is an equal‑opportunity employer. Visit for our complete Equal Employment Opportunity statement. We consider qualified applicants with arrest and conviction records where permitted by law. #J-18808-Ljbffr Bristol-Myers Squibb