Sachin Gundecha
22
Seguidores
Personal Information
Organización/Lugar de trabajo
Pune Area, India India
Ocupación
Senior Manager Regulatory Affairs
Sector
Medical / Health Care / Pharmaceuticals
Acerca de
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.