Regulatory Product Manager
10-2015 - NowPersonal services Regulatory Product Manager for marketed products: vaccines, human and equine immunoglobulins
• Management of a product portfolio: products marketed through Marketing Authorization, Temporary Authorization for Use or Export Declaration
• Regulatory Submissions:
- Europe: preparation of variations in MRP, answers to questions
- Canada: variations, answers to questions, Yearly Biologic Product Report
- US: answers to questions
• Contact with Health Authority: meeting with ANSM, response to questions in the context of an inspection
• Liaise with local affiliates, CMC team and Industrial Operations in the frame of answers to questions from Health Authorities in the international area