Associate Director, GRS Heme/Onc
Bristol Myers Squibb
August 11, 2026
Remote friendly (Princeton, NJ)
United States
Other
Responsibilities:
- In conjunction with the Team leader, develop global regulatory strategy for development and life cycle management considering relevant guidance, commercial needs, and company objectives.
- Lead regulatory dossier submissions to global and/or FDA (IND, BLA, NDA, and supplements) using internal/external resources; ensure appropriate quality controls for compliant submissions.
- Work with cross-functional groups to define and manage contributions to submissions.
- Participate in or lead the regional Regulatory Sub-team for assigned product(s)/project(s).
- Write regulatory documents (e.g., new INDs, briefing book content, BT Designation requests, Priority Review Requests, ODD) and review core documents to support IND/BLA/NDA as needed.
- Contribute to cross-functional rapid response teams to respond to CTA queries on new protocols/protocol amendments in compliance with HA deadlines.
- Participate in and/or lead regulatory interactions with FDA, as assigned.
- With the global regulatory team (GRT), develop global submission plans and Health Authority interaction plans.
Qualifications/Skills:
- Solid scientific background (PhD, MD, Pharm.D., BS or MS in regulatory science).
- 4–8 years pharmaceutical industry experience; significant regulatory affairs experience (e.g., 3–5 years).
- Thorough knowledge of drug development process, IND and NDA process.
- Demonstrated experience preparing FDA submissions; strong US regulatory submissions/dossiers (e.g., INDs, NDAs).
- Ability to partner and influence outcomes; lead teams; represent regulatory functions on project teams within BMS and across alliance.
- Innovate, analyze, and solve problems with minimal supervision; strong attention to detail; ownership of results.
- Communicates clearly and transparently; experience applying project management techniques and managing meetings.
- Ability to facilitate issue resolution, conflict management, negotiate/influence, drive quality decisions, organize/prioritize tasks, coordinate global activities.
- Some travel may be required.
Application instructions:
- If your background doesn’t perfectly match, you’re encouraged to apply anyway.
- In conjunction with the Team leader, develop global regulatory strategy for development and life cycle management considering relevant guidance, commercial needs, and company objectives.
- Lead regulatory dossier submissions to global and/or FDA (IND, BLA, NDA, and supplements) using internal/external resources; ensure appropriate quality controls for compliant submissions.
- Work with cross-functional groups to define and manage contributions to submissions.
- Participate in or lead the regional Regulatory Sub-team for assigned product(s)/project(s).
- Write regulatory documents (e.g., new INDs, briefing book content, BT Designation requests, Priority Review Requests, ODD) and review core documents to support IND/BLA/NDA as needed.
- Contribute to cross-functional rapid response teams to respond to CTA queries on new protocols/protocol amendments in compliance with HA deadlines.
- Participate in and/or lead regulatory interactions with FDA, as assigned.
- With the global regulatory team (GRT), develop global submission plans and Health Authority interaction plans.
Qualifications/Skills:
- Solid scientific background (PhD, MD, Pharm.D., BS or MS in regulatory science).
- 4–8 years pharmaceutical industry experience; significant regulatory affairs experience (e.g., 3–5 years).
- Thorough knowledge of drug development process, IND and NDA process.
- Demonstrated experience preparing FDA submissions; strong US regulatory submissions/dossiers (e.g., INDs, NDAs).
- Ability to partner and influence outcomes; lead teams; represent regulatory functions on project teams within BMS and across alliance.
- Innovate, analyze, and solve problems with minimal supervision; strong attention to detail; ownership of results.
- Communicates clearly and transparently; experience applying project management techniques and managing meetings.
- Ability to facilitate issue resolution, conflict management, negotiate/influence, drive quality decisions, organize/prioritize tasks, coordinate global activities.
- Some travel may be required.
Application instructions:
- If your background doesn’t perfectly match, you’re encouraged to apply anyway.