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Moderna

Associate Director, Global Regulatory Science, CMC

Moderna

Senior

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

What this role is

Lead CMC regulatory strategy development and global submissions for Moderna's mRNA medicine portfolio, working across multiple programs to guide manufacturing and quality teams while representing the company to health authorities. This role suits experienced regulatory professionals with deep biologics expertise who want to shape innovative medicine development at a company-wide scale.

Our summary, not Moderna’s wording. The full posting is on their site.

Skills this role names

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What they ask for

Required

  • BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field
  • 10+ years pharmaceutical or biotech industry experience with manufacturing and/or analytical focus
  • 8+ years biologics-focused regulatory CMC experience
  • Strong knowledge of EU and rest-of-world regulations
  • Strong knowledge of cGMP
  • Strong experience with CTD format and content in regulatory filings
  • Exceptional written and oral communication

Nice to have

  • MS degree in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field
  • Multidisciplinary focus on vaccines, oncology, and/or rare diseases

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