Associate Director, Regulatory Cmc Cell And Gene Therapy

Bristol Myers Squibb

Warsaw, Poland
Base: zł361,740 - zł438,337; bonus/equity: + incen...
50% onsite
Cmc regulatory strategy
Global regulatory frameworks
Health authority interactions
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 and to do it in an organization that values expertise, rewards initiative, and operates at the frontier of biomedical innovation.

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
  • global regulatory frameworks
  • Health Authority interactions
  • drug development timelines
  • regulatory paradigm shifts

Nice-to-have

  • strategic bridge between science and regulation
  • sees around corners
  • globally connected environment
  • mission-driven work
  • transformative medicines

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
  • Familiarity with electronic dossier systems

Work Rights

Not specified

Tailored Resume

Cover Letter