Description
The Regulatory Affairs Specialist will join the Group Regulatory Affairs department, reporting to the Regulatory Affairs Manager for the Products division. The main responsibility involves translating the CMC regulatory strategy and ensuring the maintenance or geographical expansion of marketing authorizations (MAs) in compliance with local and international regulations. This includes defining strategies for CMC variation registrations and dossier drafting, coordinating preparations and reviews of regulatory documents, implementing medical device-related regulatory requirements, organizing authority interactions, and providing regulatory information for database updates.
