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 from Switzerland, Sweden, France or the UK.
3 days per week in the Basel office
2 days per week in the Stockholm office
Remote in the UK and France