Associate Director, Regulatory CMC (Small Molecule)
BeiGeneUnited States
Posted December 31, 2025
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
BeOne is seeking an experienced regulatory professional to manage, evaluate, and complete regulatory projects consistent with company goals.
Requirements
- Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project
- Develop regulatory strategy and execute in the preparation of timely responses to small molecule CMC regulatory questions
- Work collaboratively with cross-functional leads and communicates CMC regulatory strategies for the assigned projects
- Lead regulatory risk assessment, identify key CMC regulatory issues and mitigation activities needed throughout product life cycle
Benefits
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
