Senior Manager Regulatory CMC

3 weeks ago


Manchester, 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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