Associate Director, Regulatory Cmc Cell And Gene Therapy

Bristol Myers Squibb

Warsaw, Poland
Base: zł361,740 - zł438,337; bonus/equity: + incen...
50% onsite
8+ years pharmaceutical industry experience
5+ years cmc regulatory strategy
Leading cross-functional matrix teams
This role serves as the strategic bridge between the science of medicine production and global regulatory frameworks to ensure safe and efficient patient access

Job Summary

  • This role serves as the strategic bridge between the science of medicine production and global regulatory frameworks to ensure safe and efficient patient access.
  • The successful candidate will own end-to-end CMC regulatory strategy from early clinical trials through post-approval changes and full lifecycle management.
  • Employees benefit from a mission-driven environment where their work directly influences drug development timelines, global market access, and patient outcomes.

Matching Summary

This role serves as the strategic bridge between the science of medicine production and global regulatory frameworks to ensure safe and efficient patient access.

Salary

Base: zł361,740 - zł438,337; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Competitive benefits, services and programs provided

Skills & Requirements

Must-have

  • 8+ years pharmaceutical industry experience
  • 5+ years CMC regulatory strategy
  • Leading cross-functional matrix teams
  • Global Health Authority interactions
  • Small molecules biologics cell therapy knowledge

Nice-to-have

  • Advanced scientific or regulatory degree
  • Electronic dossier system familiarity
  • Strategic leadership in oncology immunology
  • Ability to anticipate regulatory paradigm shifts

Key Requirements

  • BA/BS degree minimum with advanced degree preferred
  • Track record of leading teams and projects
  • Solid knowledge of global CMC regulatory requirements
  • Experience with electronic dossier systems

Work Rights

Not specified

Tailored Resume

Cover Letter