Regulatory affairs CMC Consultant

2 weeks ago

United Kingdom Life Science People Full time

Regulatory affairs CMC Consultant

Remote

Tasks & 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 strategic aspects with CDMOs
  • Coordination of filing activities within the cross-functional team and with contributing parties
  • Continued observance of regulatory guidance and regulations

Requirements:

  • Ph.D. 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 preclinical 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)

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