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.

Qualifications & Required/Preferred Skills:
- 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.

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

Application instruction:
- Apply even if your background doesn’t perfectly match—submit an application if the role intrigues you.