Sachin Gundecha

Pune Area, India India

Senior Manager Regulatory Affairs

Medical / Health Care / Pharmaceuticals

Worked for USA (ANDA). Review and compilation of ANDA, WHO dossier. CMC Writing/Annual Report preparation/CBE 30 Filing/Amendments. WHO pre-qualification dossier. Worked for ROW market, for Asia and Africa. Compiled ACTD, CTD, and Other country specific formats. Filed marketing authorization to TFDA, KFDA,PRA in CTD formats. Handling query and technical issues of the products. Providing regulatory support to the company in order to obtain marketing authorization for commercial products. Strong regulatory background includes knowledge of international registration guidelines & regulations. The work profile also includes the review of various master documents.