BeOne Medicines Ltd is seeking a Senior Director of Regulatory Affairs, CMC to lead their U.S. biologics regulatory activities. This remote position requires extensive experience in regulatory CMC for biologics, with a focus on strategic leadership, compliance, and team management in the biopharmaceutical industry
Job Summary
This role provides strategic and operational leadership for U.S.-based biologics Regulatory CMC activities and serves as a key partner to the China-based counterpart and global cross-functional stakeholders in the development and execution of global CMC regulatory strategies across the product lifecycle.
The position manages a U.S.-based team of approximately 15 reports and reports to the Global Head of Regulatory CMC.
BeOne is committed to fair and equitable compensation practices, offering a comprehensive benefits package including Medical, Dental, Vision, 401(k), and equity opportunities.
Matching Summary
Match Score: 85
BeOne Medicines Ltd is seeking a Senior Director of Regulatory Affairs, CMC to lead their U.S. biologics regulatory activities. This remote position requires extensive experience in regulatory CMC for biologics, with a focus on strategic leadership, compliance, and team management in the biopharmaceutical industry.
Salary
$204,500.00 - $274,500.00 annually
Skills & Requirements
Must-have
Biologics Regulatory CMC
Health Authority Interactions
Global CMC Regulatory Strategies
Monoclonal Antibodies and ADCs
Cell Therapies and Combination Products
Nice-to-have
Scientific and business professionals
Fighting cancer
Collaborative and motivated
External forums and industry groups
Key Requirements
12+ years pharmaceutical/biopharmaceutical experience
10+ years direct Regulatory CMC experience
Experience leading teams of 10+
BA/BS Degree (MS/PhD preferred)
Experience with gene/cell therapy/medical device-combination products is highly desirable
In-depth knowledge of ICH guidelines
Experience with Regulatory Information Management systems is a plus