Executive Director, Regulatory Affairs, CMC
Employment type
Full-time
Work setting
On-site
Location
Emeryville, CA
Schedule
Day shift
Posted
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Job overview
The Executive Director, Regulatory Affairs, CMC is an onsite role based in Emeryville, CA. Compensation is not specified for this position, which supports the Regulatory Affairs team. This role exists to provide strategic and operational leadership for U.S.-based biologics Regulatory CMC activities, ensuring high-quality, compliant, and timely filings that support clinical development and commercialization goals.
What you'll do
- Lead the U.S. Biologics Regulatory CMC team
- oversee global biologics CMC strategies
- manage health authority interactions
- partner with cross-functional stakeholders
- lead regulatory risk management
- improve SOPs.
What we're looking for
- Education
- BA/BS Degree in scientific disciplines; MS/PhD preferred.
- Experience
- 14+ years of relevant pharmaceutical experience, including at least 8 years of direct Regulatory CMC experience.
- Skills & competencies
- full-timeday shiftemeryville cabeone medicinesregulatory affairscmcbiologicsleadershipcompliancestrategyno on-callvisa sponsorship not specified
- Work arrangement
- Weekend coverage required
About the employer
BeOne Medicines is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.
Additional details
- Industry sector
- 54
- Industry
- Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Occupation code
- 11-9199.01
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Listing ID: 4a6671eb-d2d8-4bf3-aff5-05a13e877dec