Vrishali Gaonkar

Regulatory Affairs Officer @Bristol Laboratories Ltd

Mumbai, IN

Dossier preparation, Compilation, review and submission as per CTD/ ACTD country specific guidelines. To resolve queries raised by various regulatory authorities within a specified timeline. Coordinate with factory QA for arranging technical data necessary for dossier submission. To apply for COPP. To update and maintain product registration status. Email Circulation of MA grant, Request for further information (RFI), Acknowledgement notification, receipt of submission received from MHRA for proposed quality or safety variation or baseline dossier submission and notifications received from RMS or CMS countries for which the submissions have been done by using Decentralized procedure (DCP). To keep track of the circulation activity. To update excel for Approval circulation to CMO. To check the updated product License revision history, Product License file and archive the files in the appropriate folders.

HK College Of Pharmacy

Master's degree

savitribai Phule pune university

B.Pharm

University of Mumbai

PG Diploma