CMC Regulatory Consultant
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.
Location:
The role is based in Munich and requires 3 days/week on site
Role:
- 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
Apply:
For more information, or to apply for this CMC Regulatory Consultant position please contact Mary Bolt on 01246 457729 or email mbolt@ckgroup.co.uk. Please quote job reference 104625 in all correspondence.