You'll be the primary regulatory CMC voice on cross-functional matrix teams, covering everything from early clinical trial applications through to new marketing authorizations, post-approval changes, and full lifecycle management
Job Summary
You'll be the primary regulatory CMC voice on cross-functional matrix teams, covering everything from early clinical trial applications through to new marketing authorizations, post-approval changes, and full lifecycle management.
You'll interface directly with Health Authorities on CMC submissions and CMC-related issues, representing BMS at the highest levels of regulatory dialogue.
This role is an exceptional opportunity for a seasoned CMC regulatory professional who is ready to step into a position of real strategic leadership in an organization that values expertise and rewards initiative.
Matching Summary
You'll be the primary regulatory CMC voice on cross-functional matrix teams, covering everything from early clinical trial applications through to new marketing authorizations, post-approval changes, and full lifecycle management.
Salary
Base: zł361,740 - zł438,337; Bonus/Equity: Additional incentive cash and stock opportunities may be available; Benefits: Not specified
Skills & Requirements
Must-have
CMC Regulatory Strategy
Cell and Gene Therapy
Global Regulatory Frameworks
Health Authority Interactions
Lifecycle Management
Nice-to-have
Translating science to regulation
Anticipating regulatory paradigm shifts
Driving global change management
Shaping process and policy
Thrive in a globally connected environment
Key Requirements
8+ years pharmaceutical industry experience
5+ years CMC regulatory strategy
BA/BS degree minimum
Track record of leading teams
Solid knowledge of global CMC regulatory requirements