Leading health authority interactions and responses
BeOne Medicines Ltd is seeking a Senior Manager for Regulatory CMC (small molecule) who will be responsible for leading regulatory projects and strategies in a collaborative environment focused on cancer treatment. The ideal candidate will have extensive regulatory experience in the pharmaceutical industry and a strong scientific background
Job Summary
BeOne Medicines is seeking an experienced professional to lead small molecule CMC regulatory strategies and ensure high-quality global submissions for cancer treatments.
The role involves developing regulatory plans, managing Health Authority interactions, and providing critical support to cross-functional teams on process optimizations.
Candidates will benefit from a comprehensive benefits package including medical, dental, vision, 401(k), and opportunities for discretionary equity awards.
Matching Summary
Match Score: 85
BeOne Medicines Ltd is seeking a Senior Manager for Regulatory CMC (small molecule) who will be responsible for leading regulatory projects and strategies in a collaborative environment focused on cancer treatment. The ideal candidate will have extensive regulatory experience in the pharmaceutical industry and a strong scientific background.
Salary
Base: $135,200.00 - $180,200.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, Wellness
Skills & Requirements
Must-have
7+ years pharmaceutical regulatory CMC experience
Authoring complex CTD M2 and M3 sections
Leading Health Authority interactions and responses
In-depth knowledge of ICH and US/EU regulations
Experience with NDA/MAA submission preparation
Nice-to-have
Familiarity with Veeva software systems
Knowledge of rest of world regulatory requirements
Demonstrated leadership as a people manager
Experience in chemical process or formulation development
Comfortable in entrepreneurial fast-paced environment
Key Requirements
BA/BS degree required; MS/PhD preferred
Minimum 7 years related industry experience
Proven record leading Health Authority interactions
Expertise in at least one pharmaceutical development area