CMC Regulatory Consultant

  • Salary: Competitive
  • REF Number: v-104625
  • Consultant: Mary Bolt
  • Contact: 01246457729
  • Date Published: 20.06.2024
  • Industry: Pharmaceutical
  • Location: Munich, Germany
  • Functional Expertise: Drug Safety & Pharmacovigilance, Regulatory Affairs

CK Group are recruiting for a CMC Regulatory Consultant to join a dedicated and well established consulting company who are based in Munich on a permanent basis.


The role is based in Munich and requires 3 days/week on site


  • Provide advice to clients on quality aspects of drug development and regulatory requirements, in close collaboration with cross-functional experts from the team.
  • Ensure that the content of CMC work-packages and documentation are phase appropriate, meet regulatory expectations and enable approval of regulatory submissions.
  • Prepare quality sections for MAA and BLA/NDA as well as for IMPD and IND.
  • Perform gap analyses of client-provided packages. Identify critical CMC development issues and develop strategies for their resolution.
  • Support due diligence processes.
  • Prepare briefing packages for agency meetings (e.g. scientific advice, oral explanation, EoP2) and conduct such meetings together with the client.

Your Background:

  • Educated to Ph.D. or master’s degree level in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology or a related field.
  • Extensive experience in a scientific/technical Regulatory CMC development role.
  • Experience with regulatory filings (IND/IMPD, BLA/NDA/MAA).
  • Excellent communication and negotiation skills in English. German language skills are a plus.
  • Experience with CMC and regulatory requirements for all development stages, from pre-clinical to Phase III or commercial.
  • Highly motivated team player with strong interpersonal abilities


For more information, or to apply for this CMC Regulatory Consultant position please contact Mary Bolt on 01246 457729 or email Please quote job reference 104625 in all correspondence.





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