Associate Director Global Regulatory Sciences - Oncology
Bristol Myers Squibb
August 13, 2026
Remote friendly (Princeton, NJ)
United States
Corporate Functions
Associate Director, Global Regulatory Strategy, Hematology/Oncology
Position Responsibilities (Global and US Regulatory Lead)
- Develop global regulatory strategy across development and life-cycle management considering guidance, commercial needs, and company objectives.
- Lead global and/or FDA dossier submissions (IND, BLA, NDA, supplements), using internal/external resources; ensure quality controls for compliant submissions.
- Coordinate with cross-functional teams to define and manage submission contributions.
- Write/review regulatory documents (e.g., new INDs, briefing books, BT designation requests, Priority Review Requests, ODD) to support IND/BLA/NDA with EUL/GRL as needed.
- Serve on/lead rapid response teams to address CTA queries on new protocols/amendments per Health Authority deadlines.
- Participate in and/or lead FDA regulatory interactions as assigned.
- With global regulatory team, develop global submission plans and Health Authority interaction plans.
Skills/Requirements
- PhD, MD, Pharm.D., BS or MS in regulatory science (solid scientific background).
- 4–8 years pharmaceutical industry experience; 3–5 years in regulatory affairs.
- Thorough knowledge of drug development; IND and NDA processes; demonstrated FDA submission experience.
- Strong US regulatory submissions/dossier experience (INDs, NDAs).
- Team-oriented; ability to influence outcomes; demonstrated leadership.
- Innovate/analyze/solve problems with minimal supervision and strong attention to detail.
- Project management experience; ability to manage meetings.
- Travel may be required.
Compensation/Benefits (as stated)
- Cambridge Crossing: $199,350–$241,566; Princeton, NJ: $173,350–$210,058.
- Health coverage; wellbeing support; 401(k); disability and life insurance (plus other listed protections). Paid time off and global shutdown also described.
Application instruction
- If the role interests you but doesn’t perfectly match your resume, apply anyway.
Position Responsibilities (Global and US Regulatory Lead)
- Develop global regulatory strategy across development and life-cycle management considering guidance, commercial needs, and company objectives.
- Lead global and/or FDA dossier submissions (IND, BLA, NDA, supplements), using internal/external resources; ensure quality controls for compliant submissions.
- Coordinate with cross-functional teams to define and manage submission contributions.
- Write/review regulatory documents (e.g., new INDs, briefing books, BT designation requests, Priority Review Requests, ODD) to support IND/BLA/NDA with EUL/GRL as needed.
- Serve on/lead rapid response teams to address CTA queries on new protocols/amendments per Health Authority deadlines.
- Participate in and/or lead FDA regulatory interactions as assigned.
- With global regulatory team, develop global submission plans and Health Authority interaction plans.
Skills/Requirements
- PhD, MD, Pharm.D., BS or MS in regulatory science (solid scientific background).
- 4–8 years pharmaceutical industry experience; 3–5 years in regulatory affairs.
- Thorough knowledge of drug development; IND and NDA processes; demonstrated FDA submission experience.
- Strong US regulatory submissions/dossier experience (INDs, NDAs).
- Team-oriented; ability to influence outcomes; demonstrated leadership.
- Innovate/analyze/solve problems with minimal supervision and strong attention to detail.
- Project management experience; ability to manage meetings.
- Travel may be required.
Compensation/Benefits (as stated)
- Cambridge Crossing: $199,350–$241,566; Princeton, NJ: $173,350–$210,058.
- Health coverage; wellbeing support; 401(k); disability and life insurance (plus other listed protections). Paid time off and global shutdown also described.
Application instruction
- If the role interests you but doesn’t perfectly match your resume, apply anyway.