Manager - Drug Regulatory Affairs

Manager - Drug Regulatory Affairs (Europe)
GenNext Human Resource Management - Mumbai, Maharashtra

1) Complete DCP, MRP & National application management. 2) Preparation of Module 1 for EU filings or module 1 support to customer 3) Variation/post authorization submissions management with authorities. 4) Renewal applications submissions. 5) Liaise/communicate with the EU agencies for procedure management. Knowledge of applying DCP slots to various EU agencies. Writing Read More» 1) Complete DCP, MRP & National application management. 2) Preparation of Module 1 for EU filings or module 1 support to customer 3) Variation/post authorization submissions management with authorities. 4) Renewal applications submissions. 5) Liaise/communicate with the EU agencies for procedure management. Knowledge of applying DCP slots to various EU agencies. Writing to agencies for taking scientific and regulatory advise as per need and time 6) Knowledge of all the EU member states. For more info visit at mentioned link