Preparing high quality dossier part Module 3 (CMC part) for the products in Sanofi’s local portfolio, and performing all renewal, variation applications as well as answering and ensuring all health authority requirements for the life cycle of all portfolios.- Preparing Module 3 CMC part of dossier for Sanofi products in time.- Preparing the variations and MA renewal dossiers for registered products.- Management of deficiency letters – preparation of answers and send complete answer on time.- Ensuring the regulatory compliance of registered information in the operation.- Preparing technical dossiers and driving the technical correspondences with the relevant departments of co-development partner companies- To compile variation dossiers for Sanofi transfer projectsPursue
progress, discover
extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
