Associate Director, GRS Heme​/Onc

Responsibilities

• In conjunction with Team leader, develop global regulatory strategy through development and lifecycle management.
• Lead regulatory dossier submissions to global and/or FDA (IND, BLA, NDA, supplements), ensuring quality controls for compliant submissions.
• Coordinate cross-functional contributions to submissions.
• Participate in or lead regional Regulatory Sub-team for assigned product(s)/project(s).
• Write and review regulatory documents supporting IND/BLA/NDA and related requests (e.g., new INDs, briefing materials, BT Designation, Priority Review Requests, ODD).
• Respond to Clinical Trial Application (CTA) queries for new protocols/amendments in compliance with Health Authority deadlines.
• Participate in and/or lead regulatory interactions with FDA, as assigned.
• With Global Regulatory Team (GRT), develop global submission and Health Authority interaction plans.
• Some travel may be required.

• Solid scientific background (PhD/MD/Pharm.D./BS or MS in regulatory science) and 4–8 years pharmaceutical industry experience; 3–5 years in regulatory affairs.
• Thorough knowledge of drug development, IND, and NDA processes.
• Demonstrated experience preparing FDA submissions; strong US regulatory submissions/dossiers (INDs, NDAs).
• Experience leading teams; represent regulatory function on project teams within BMS and alliances.
• Ability to innovate, analyze, problem-solve with minimal supervision; strong attention to detail.
• Strong partnering, communication, project management/meeting management, issue resolution, and global coordination skills.

• Princeton, NJ, US: $173,350–$210,058.
• Health coverage and wellbeing support; 401(k) and disability/life insurance (details on eligibility/enrollment).