Senior Manager Regulatory CMC
3 weeks ago
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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