Senior Manager Regulatory CMC

3 weeks ago


United Kingdom BioTalent Full time

BioTalent are pleased to be supporting a longstanding client, a mid-sized biopharmaceutical business with offices across Europe, in their search for a Senior Manager Regulatory CMC, responsible for Dossier Management.


The client would like to speak to candidates with experience in:


  • Development activities for Biologics in the EU and US.
  • Post-approval activities for Biologics in International markets (China, Russia, Latam, Asia etc.)
  • OR pre and post approval activities for small molecule products - Global experience.


Responsibilities would include:

  • Dossier Strategy
  • Authoring CMC dossier sections
  • Developing the technical eCTD sections to support Regulatory CMC dossier applications
  • Interfacing with internal and external functional stakeholders


The role can be worked remotely within Switzerland, Sweden, France or the UK.



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