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BeOne Medicines is seeking a Senior Director of Regulatory Affairs, CMC, to lead their U.S. Biologics Regulatory CMC activities. The ideal candidate will have extensive experience in regulatory compliance and team leadership within the biopharmaceutical industry, particularly in biologics development.
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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.
The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
Matching Summary
Match Score: 75
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BeOne Medicines is seeking a Senior Director of Regulatory Affairs, CMC, to lead their U.S. Biologics Regulatory CMC activities. The ideal candidate will have extensive experience in regulatory compliance and team leadership within the biopharmaceutical industry, particularly in biologics development.
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Salary
$204,500.00 - $274,500.00 annually; Bonus/Equity: Eligible for annual bonus plan and equity awards; Benefits: Comprehensive benefits package
Skills & Requirements
Must-have
Biologics Regulatory CMC
Health Authority interactions
CMC regulatory strategies
CTD Modules 2 and 3
Product lifecycle management
Nice-to-have
Collaborative Spirit
Bold Ingenuity
Driving Excellence
Patients First
Key Requirements
12+ years pharmaceutical/biopharmaceutical experience