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Bristol Myers Squibb

Associate Director, Global Regulatory Sciences - CMC

Bristol Myers Squibb

full time · Senior

$164,020 – $198,759

Listed on Bristol Myers Squibb’s own careers site. You apply with them directly — we never stand between you and the employer.

What this role is

This role involves developing and managing regulatory compliance documentation for pharmaceutical and cell therapy products across their lifecycle, from clinical trials through post-approval. It suits experienced regulatory professionals who can independently guide technical teams on complex CMC requirements and interface with health authorities on submissions.

Our summary, not Bristol Myers Squibb’s wording. The full posting is on their site.

Skills this role names

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What they ask for

Required

  • Bachelor's degree
  • 8+ years pharmaceutical industry experience
  • 5+ years CMC regulatory strategy experience
  • Knowledge of CMC regulatory requirements for advanced therapies, small molecules, biologics, and cell therapy
  • Ability to independently manage complex projects with minimal supervision
  • Experience leading teams and representing regulatory functions across project teams
  • Strong written and oral communication skills
  • Experience with regulatory submissions and dossier systems

Nice to have

  • Knowledge of small molecules, biotechnology, or cell therapy products
  • Expertise in biological or cell therapy modalities and drug development processes
  • Experience developing and documenting regulatory strategies in coordination with clinical plans
  • Experience facilitating issue resolution and conflict management

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