Regulatory CMC Specialist
vor 1 Tag
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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