Pharmaceuticals

CMC Consultant

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About the job

Do you have 5+ years of experience in a technical CMC role? Are you looking to join a growing organisation that offers a flexible working environment, a competitive salary package and a hybrid remote work model?

Invenia Group has partnered with a renowned regulatory consultancy, based in Munich, Germany. The company is currently searching for a Regulatory CMC Consultant to join the growing team. This position will offer the correct candidate the opportunity to offer consultative advice to a range of companies in industry and give a broad oversight of drug products and drug substances on the market (from pre-clinical through to marketing).

Role responsibilities:

If successful, you will be responsible for providing advice to clients on quality aspects of drug development and regulatory requirements, in close collaboration with cross-functional experts from the team. You will also be responsible for the following:

  • Preparation of quality sections for MAA and BLA/NDA as well as for IMPD and IND
  • Identify critical CMC development issues and develop strategies for their resolution
  • Offer support with due diligence
  • 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

What we are looking for: 

We are looking for someone with a Ph.D. or master’s degree in pharmacy, chemistry, biopharmaceuticals, biochemistry, biology or comparable. You should have 5+ years of experience in a technical CMC role, as well as experience with CMC and regulatory requirements for all development stages, from pre-clinical to Phase III or commercial.

You should have previous experience with regulatory filings (IND/IMPD, BLA/NDA/MAA), fluency in the English language, as well as a willingness to travel moderately (meetings with clients, agencies or CMOs).

This is a fantastic opportunity to join this growing organisation that offers a flexible working environment, a competitive salary package and a hybrid remote work model. To find out more information regarding this opportunity, please apply.