Director, Regulatory CMC - Cell Therapy
Bristol Myers Squibb
August 13, 2026
Remote friendly (Madison, NJ)
United States
Operations
Responsibilities:
- Oversee management of multiple development and life-cycle management projects for varying priorities/complexity.
- Represent GRS-CMC on cross-functional teams, governance committees, and due diligence/in-licensing; represent BMS at Health Authority meetings.
- Serve as spokesperson to stakeholders/Health Authorities; develop and communicate regulatory strategy based on global guidelines.
- Develop/communicate strategic direction; prepare/oversee CMC submissions (thorough, complete, timely) and review submissions for strategic/technical clarity.
- Use electronic systems for dossier creation, review, and tracking.
- Manage and support growth/development of direct reports; participate in leadership/department meetings.
- Anticipate and communicate regulatory paradigm shifts; represent GRS-CMC in fact-finding meetings/R&D forums.
- Support CMC policies/procedures; ensure regulatory compliance by monitoring/verifying timely and accurate data entry in Regulatory Information Management.
Qualifications:
- Minimum BA/BS.
- 10+ years pharmaceutical/related experience (multidiscipline preferred); 8+ years regulatory CMC experience.
Key skills/competencies (required/preferred):
- CMC regulatory knowledge for advanced therapies/cell therapy (development and post-approval as applicable); strong understanding of drug development, upstream/downstream, analytical methods.
- Ability to lead cross-functional teams, prioritize multiple projects, work independently; negotiate/influence and resolve issues.
- Experience engaging health authorities; translate complex science into logical components.
- Strong policy/law/regulatory guideline knowledge globally; excellent written/verbal communication of strategy/issues/risks.
- Proficient with electronic systems; travel up to 5%.
Benefits (if eligible):
- Health coverage (medical/pharmacy/dental/vision); wellbeing support; 401(k), disability and life insurance; paid time off (incl. flexible time off for US exempt employees) and other leave/global shutdown options.
Application instruction:
- Apply even if your experience doesn’t perfectly match.
- Oversee management of multiple development and life-cycle management projects for varying priorities/complexity.
- Represent GRS-CMC on cross-functional teams, governance committees, and due diligence/in-licensing; represent BMS at Health Authority meetings.
- Serve as spokesperson to stakeholders/Health Authorities; develop and communicate regulatory strategy based on global guidelines.
- Develop/communicate strategic direction; prepare/oversee CMC submissions (thorough, complete, timely) and review submissions for strategic/technical clarity.
- Use electronic systems for dossier creation, review, and tracking.
- Manage and support growth/development of direct reports; participate in leadership/department meetings.
- Anticipate and communicate regulatory paradigm shifts; represent GRS-CMC in fact-finding meetings/R&D forums.
- Support CMC policies/procedures; ensure regulatory compliance by monitoring/verifying timely and accurate data entry in Regulatory Information Management.
Qualifications:
- Minimum BA/BS.
- 10+ years pharmaceutical/related experience (multidiscipline preferred); 8+ years regulatory CMC experience.
Key skills/competencies (required/preferred):
- CMC regulatory knowledge for advanced therapies/cell therapy (development and post-approval as applicable); strong understanding of drug development, upstream/downstream, analytical methods.
- Ability to lead cross-functional teams, prioritize multiple projects, work independently; negotiate/influence and resolve issues.
- Experience engaging health authorities; translate complex science into logical components.
- Strong policy/law/regulatory guideline knowledge globally; excellent written/verbal communication of strategy/issues/risks.
- Proficient with electronic systems; travel up to 5%.
Benefits (if eligible):
- Health coverage (medical/pharmacy/dental/vision); wellbeing support; 401(k), disability and life insurance; paid time off (incl. flexible time off for US exempt employees) and other leave/global shutdown options.
Application instruction:
- Apply even if your experience doesn’t perfectly match.