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
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- To compile variation dossiers for Sanofi transfer projects