Associate Director, Regulatory Affairs, CMC
BeiGeneUnited States
Posted February 13, 2026
142000 - 192000 USD
Full Time
About the Company
Effective March 17, 2025, The U.S. subsidiary of BeiGene, Ltd. has changed its name to BeOne Medicines USA, Inc. This change comes ahead of our anticipated global rebranding to BeOne Medicines Ltd. and redomiciliation to Switzerland, pending shareholder approval. The new name reflects our commitment to develop innovative medicines and partner with the global community to help as many patients with cancer as possible. To learn more about BeOne Medicines, please follow our new LinkedIn profile @BeOne Medicines.
Job Description
The Associate Director, Regulatory Affairs, CMC is responsible for developing and implementing global regulatory CMC strategies to secure and maintain market access for assigned product(s) in line with business objectives.
Requirements
- Serve as the regulatory CMC representative on project teams
- Manage interactions with FDA and other global regulatory authorities
- Develop and implement effective regulatory CMC strategies for global submissions
- Manage, prepare, and/or author CMC document packages for global regulatory submissions
- Review technical reports and CMC sections of IND, CTA, BLA, MAA, and other global submissions
- Actively participate as a member of global regulatory teams and CMC subteams
Benefits
- Medical, Dental, Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
