Sauravkumar Dubey
Regulatory Affairs Associate @ DDReg Pharma | Document Review, Client Coordination
- Role
- Regulatory Affairs Associate L2 at DDReg Pharma Pvt. Ltd.
- Location
- Gurugram, HR, IN
- LinkedIn followers
- 500 followers
About Sauravkumar Dubey
DDReg Pharma empowers regulatory compliance through expertise in dossier preparation, variation packages, and artwork reviews. As a Regulatory Affairs Associate, contributed to the preparation and cross-checking of comprehensive dossiers for solid, injectable, biosimilar, and medical device formulations, ensuring alignment with national regulatory authority (NRA) guidelines. Collaborative client coordination enabled efficient document review and feedback resolution. Sankalchand Patel University laid the foundation with a Bachelor of Pharmacy degree, complemented by hands-on training in manufacturing and quality control at Dynamism Lab. This academic and practical background drives a commitment to regulatory excellence, leveraging insights into compliance, client relationships, and regulatory guidelines to support global pharmaceutical submissions.
Experience
Regulatory Affairs Associate L2
Jul 2023 — Present · Gurugram, IN
Dosage form @ Solid, injectable, bio similar, medical device.•Reviewing of administrative checklist in line with NRA guidelines & drafts of regulatory fillings (initial & LCM) prepared by Doer.•Coordinate with client for ongoing dossier documents and perform work on received documents to write dossier (M1, QOS & M3).•Reviewing information obtained from client during the dossier preparation and providing comments to sort observation.•Reviewing of product artwork for its accuracy and compliance with authority regulation.•Reviewing of dossier prepared by doer.•Cross check of all e-functionalities & temp files in final dossier before submission.•Preparation of variation package •Preparation of query response of query raised by authority.
Education
Sankalchand Patel University
Bachelor of Pharmacy - BPharm
2018 — 2022
TEF'S SARDAR SCIENCE SCHOOL
HSC
2015 — 2017
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