Are you an experienced Senior Regulatory CMC Consultant? Do you have hands-on CMC development experience in the pre-approval phase? Do you have IMPD/IND authoring experience? If so, this could be the role for you!

We are recruiting for a Senior Regulatory CMC Consultant to join a leading Regulatory Consultancy business based in Munich on a permanent basis. Full relocation packages are available. Remote working in Europe will be considered for very senior candidates. Our client offers full flexibility to manage your own workload within a professional and friendly working environment that is truly unique.

The successful candidate will become the quality expert in our clients team, providing knowledge on broad range of drug substances from small molecules to synthetic oligonucleotides to biologicals, and drug products from solid orals to sterile solutions to nanoparticulate formulations.

Responsibilities:

• 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.
• Preparation of 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.
• Management of operational and strategical aspects with CDMOs.
• Coordination of filing activities within the cross-functional team and with contributing parties.
• Continued observance of regulatory guidance and regulations.

Requirements:

• PhD or master?s degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology or comparable.
• At least five years in a scientific/technical CMC development or CMC - regulatory affairs function.
• 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.
• Sound knowledge of Microsoft Office applications.
• Willingness to travel moderately (Meetings with clients, agencies or CMOs).

Disclaimer:

This vacancy is being advertised by either Advanced Resource Managers Limited, Advanced Resource Managers IT Limited or Advanced Resource Managers Engineering Limited ("ARM"). ARM is a specialist talent acquisition and management consultancy. We provide technical contingency recruitment and a portfolio of more complex resource solutions. Our specialist recruitment divisions cover the entire technical arena, including some of the most economically and strategically important industries in the UK and the world today. We will never send your CV without your permission.