BeOne Medicines is seeking an Executive Director for Regulatory Affairs, CMC, to lead their U.S. Biologics Regulatory CMC organization. The ideal candidate will have extensive experience in regulatory submissions and a strong background in biologics, with leadership responsibilities over a team of approximately 15 professionals
Job Summary
This role provides strategic and operational leadership for U.S.-based biologics Regulatory CMC activities as a key partner to global stakeholders.
The position manages a U.S.-based team of approximately 15 reports and is accountable for high-quality, compliant regulatory submissions supporting clinical development and licensure.
BeOne Medicines offers a comprehensive benefits package including Medical, Dental, Vision, 401(k), Life Insurance, Paid Time Off, and discretionary equity awards.
Matching Summary
Match Score: 85
BeOne Medicines is seeking an Executive Director for Regulatory Affairs, CMC, to lead their U.S. Biologics Regulatory CMC organization. The ideal candidate will have extensive experience in regulatory submissions and a strong background in biologics, with leadership responsibilities over a team of approximately 15 professionals.
Salary
Base: $274,800.00 - $354,800.00 annually; Bonus/Equity: Annual bonus plan eligible; Equity: Discretionary stock awards available
Skills & Requirements
Must-have
14+ years pharmaceutical experience
8+ years direct Regulatory CMC experience
Lead Health Authority interactions
Manage CTD Modules 2 and 3 submissions
Oversee IND BLA MAA filings
Team leadership of 10+ professionals
Nice-to-have
Experience with gene therapy or cell therapy
Familiarity with Veeva Vault RIM system
Multilingual capability
Background in medical device-combination products
Strong problem-solving skills in global matrix
Key Requirements
BA/BS Degree in scientific disciplines (MS/PhD preferred)
Minimum 14 years relevant pharmaceutical experience
At least 8 years direct Regulatory CMC experience
Proven track record leading teams of 10+ members
Hands-on expertise in upstream/downstream processing or formulation