Vrishali Gaonkar
Regulatory Affairs Officer @ Bristol Laboratories, ROW Market , M. Pharm,
- Role
- Regulatory Affairs Officer at Bristol Laboratories Ltd
- Location
- Mumbai, IN
- LinkedIn followers
- 500 followers
About Vrishali Gaonkar
Currently Working as Regulatory Affairs officer for ROW Market at Bristol…
Experience
Regulatory Affairs Officer
Mar 2023 — Present · 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.
Education
HK College Of Pharmacy
Master's degree
2019 — 2021
savitribai Phule pune university
B.Pharm
2013 — 2017
University of Mumbai
PG Diploma
2019 — 2020
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