Regulatory CMC Specialist

vor 1 Tag


Munich, Bayern, Deutschland S3 Science Recruitment Vollzeit

Regulatory CMC Specialist | Biopharma | Munich

We are seeking an experienced Regulatory CMC professional with hands-on involvement across global development and registration activities. This role is ideal for someone who has directly contributed to CMC strategy and authored key submission documentation.

What You'll Do

  • Lead and contribute to CMC content for regulatory submissions (e.g., IND, IMPD, NDA, MAA, BLA)
  • Develop and review CMC sections of briefing packages and support Scientific Advice/Agency interactions
  • Partner closely with CMC, QA, Development and Manufacturing teams across the product lifecycle
  • Ensure CMC regulatory strategy aligns with global expectations and project timelines

What We're Looking For

  • Solid experience in Regulatory CMC within biotech/pharma
  • Proven track record authoring and reviewing CMC submission documents (not just coordinating)
  • Strong understanding of drug development and regulatory guidelines
  • Confident communicator with experience participating in Health Authority discussions

Why Join?

  • Influence development strategy on innovative therapies
  • Operate within a collaborative, science-driven environment
  • Competitive package + opportunity for long-term growth

Send your CV or message me directly for a confidential conversation.


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