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Moderna

Associate Director, CMC Regulatory Affairs, International

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

This role leads CMC regulatory strategy and compliance activities for Moderna's global mRNA product portfolio, managing submissions to international health authorities across vaccines, oncology, and rare diseases. It suits experienced regulatory professionals with strong biologics CMC expertise and knowledge of EU and international pharmaceutical regulations.

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

  • Bachelor's degree in Pharmaceutics, Chemistry, Chemical Engineering, or related field
  • 10+ years pharmaceutical/biotech industry experience with manufacturing and/or analytical focus
  • 8+ years biologics-focused regulatory CMC experience
  • Knowledge of EU and international (ROW) regulations
  • Knowledge of cGMP
  • Experience with CTD format and regulatory filings
  • Strong written and oral communication

Nice to have

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

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