Director Regulatory Science - ATMP
Apply NowCompany: VCLS
Location: Boston, MA 02115
Description:
Regulatory Science Director - ATMP
VCLS is seeking a seasoned Regulatory Science Director with deep expertise in Advanced Therapy Medicinal Products (ATMPs) to lead strategic regulatory development for cutting-edge cell and gene therapies.
Key Responsibilities:
Requirements
VCLS is seeking a seasoned Regulatory Science Director with deep expertise in Advanced Therapy Medicinal Products (ATMPs) to lead strategic regulatory development for cutting-edge cell and gene therapies.
Key Responsibilities:
- Provide expert regulatory guidance across the full lifecycle of ATMPs
- Lead global regulatory strategy development and submissions
- Engage with regulatory authorities and support client interactions
- Mentor and guide cross-functional project teams
Requirements
- PhD, PharmD, or equivalent in life sciences
- 10+ years in regulatory affairs, with strong ATMP experience
- Proven track record with EU/US regulatory submissions
- Excellent leadership and communication skills