Director, Regulatory CMC - Cell Therapy

GRS-CMC Director (Cell Therapy)

Responsibilities:
- Develop and communicate strategic regulatory direction based on global guidelines and experience.
- Prepare/oversee CMC submissions; ensure thoroughness, completeness, and timeliness.
- Review CMC Leads’ submissions for clarity (strategic and technical).
- Use electronic systems for dossier creation, review, and tracking.
- Manage, coach, and support growth of direct reports; participate in leadership/department meetings.
- Anticipate and communicate regulatory paradigm shifts.
- Represent GRS-CMC in product fact-finding/R&D forums and cross-functional teams; support due diligence/in-licensing.
- Represent BMS at Health Authority meetings; act as a credible spokesperson.
- Manage relationships with diverse teams; support CMC policies/procedures.
- Ensure regulatory compliance by monitoring/verifying timely and accurate regulatory data entry.

Qualifications:
- Minimum BA/BS degree.
- 10+ years pharmaceutical/related experience (prefer multidisciplinary) and 8+ years regulatory CMC experience.

Required/Preferred Skills & Competencies:
- Knowledge of CMC regulatory requirements for advanced therapies/cell therapy (development and post-approval as applicable).
- Deep understanding of advanced/bio/ cell therapy processes and analytical methods.
- Ability to lead multifunctional teams, prioritize multiple projects, and work independently.
- Proven experience influencing/negotiating and resolving issues; communicate strategy/risks to senior leadership and governing bodies.
- Strong grasp of global regulatory laws/policies/guidelines; ability to break down complex science for regulatory audiences.
- Proficient with electronic systems; travel up to 5%.

Benefits (if applicable):
- Health coverage (medical/pharmacy/dental/vision), wellbeing support, 401(k), disability/life insurance.
- Paid time off (flexible time off/annual vacation per employee category).