PRERNA T. DHARMIK

Regulatory Affairs Executive with total two years of experience filing quality post-approval regulatory submissions.

• Total Experience: About 6 Months (03/2023-till date) of experience including 1 Year (03/2023 to 03/2024) as Regulatory Affairs Executive in Intas Pharmaceuticals Ltd.
• Father's Name: Trilokkumar Ramnath Dharmik
• Mother's Name: Geeta Trilokkumar Dharmik
• Date of Birth: 11/16/98
• Gender: Female

• Angiplast Pvt. Ltd, Ahmedabad, Gujarat, QA/RA Executive, 6 months (09/2022-03/2023), Compilation and Review of Technical Files including Risk Management File, P.M.S Report, Pre-Clinical Evaluation Report, Regulatory handling of change controls and other relevant databases, Analyze and evaluate existing SOPs and record-keeping systems, Assist with training (including quality system and technical training) and maintaining training database, Review of documents for Batch manufacturing records (BMR)
• Intas Pharmaceuticals Ltd., Executive-Regulatory Affairs, 1 year (03/2023-08/2024), Prepared and ensured timely submissions of post approval variations for EU market, Primarily responsible for creation, assembly, publishing, and verification of both minor and routine regulatory post-approval variations submissions to EMA health authorities, including Type IA, IAIN and IB Variations, Responses, etc, Performed compilation, formatting and review of submissions to EMA in eCTD (electronic Common Technical Document) format, Prepared document packages for regulatory submission for Europe market, Preparation of query response raised from regulatory authority, Managing the internal RIMS database for all formulary submissions, approvals and listings., Successful track record of approvals with EU regulatory bodies, Preparing RTD’s for approvals received and publishing of RTD’s in DMS, Provided training to the team for data entry in RIMS, Co-ordinating with the CRO teams for RIMS database entry

• English
• Hindi
• Gujarati