Associate Director, Regulatory Cmc Cell And Gene Therapy

Bristol Myers Squibb

Warsaw, Poland
Base: zł361,740 - zł438,337; bonus/equity: incenti...
Hybrid (50% onsite)
8+ years pharmaceutical industry experience
5+ years cmc regulatory strategy
Leading cross-functional matrix teams
Bristol Myers Squibb is seeking an Associate Director for Regulatory CMC in Cell and Gene Therapy in Warsaw, Poland. The role focuses on developing regulatory strategies for complex medicinal products, ensuring compliance with global regulations, and leading cross-functional teams

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, developing plans that directly influence drug development timelines and commercial outcomes.
  • Employees benefit from working on a diverse portfolio including small molecules, biologics, and cell therapies within a mission-driven organization focused on transforming patients' lives.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking an Associate Director for Regulatory CMC in Cell and Gene Therapy in Warsaw, Poland. The role focuses on developing regulatory strategies for complex medicinal products, ensuring compliance with global regulations, and leading cross-functional teams.

Salary

Base: zł361,740 - zł438,337; Bonus/Equity: Incentive cash and stock opportunities available; Benefits: Wide variety of competitive benefits and programs

Skills & Requirements

Must-have

  • 8+ years pharmaceutical industry experience
  • 5+ years CMC regulatory strategy
  • Leading cross-functional matrix teams
  • Global CMC regulatory requirements knowledge
  • Health Authority interaction experience

Nice-to-have

  • Experience with cell therapy products
  • Advanced scientific or regulatory degree
  • Familiarity with electronic dossier systems
  • Ability to anticipate regulatory paradigm shifts
  • Strong communication and ownership skills

Key Requirements

  • BA/BS degree minimum (advanced degree preferred)
  • 8+ years total pharmaceutical industry experience
  • 5+ years in CMC regulatory strategy
  • Track record of leading teams and projects

Work Rights

Not specified

Tailored Resume

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