Gaurish Bagul
Regulatory Affairs Executive @ Micro Labs Limited | Postgraduate Diploma
- Role
- Regulatory Affairs Executive at Micro Labs Limited
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Gaurish Bagul
Micro Labs Limited relies on a dedicated regulatory affairs executive to compile and review dossiers for regulated markets and customer requirements. With a postgraduate diploma in regulatory affairs and hands-on experience in ANDA and WHO dossiers, the team ensures compliance with country-specific regulations and post-approval changes. Expertise includes eCTD submissions using Pharmaready and collaboration with cross-functional teams to streamline documentation processes. Previous experience in quality assurance at Agog Pharmaceuticals enhanced proficiency in deviation handling, APQR preparation, and in-process checks. Academic training from leading institutions shaped a strong foundation in GLP compliance, GMP, and regulatory documentation. Motivated by a commitment to precision and collaboration, the goal is to contribute to regulatory excellence and organizational success.
Experience
Regulatory Affairs Executive
May 2024 — Present · Bengaluru, IN
Responsible for compilation and review of dossier for a product for the regulated markets and Customers* Preparation and compilation of ANDA and /WHO dossier as per counrty specific requirements *Circulate query checklist and compile query response *Compilation and submission for post approval changes / supplement for US market*Hyperlink and upload the dossier in eCTD software (Pharmaready)* Coordinate with R&D, QA,QC/Clinical/IPR and production for documents
Education
Institute of Pharmaceutical Management
Postgraduate Degree, Drug Regulatory Affairs
K.B.H.S.S. Trust's Institute of pharmacy,Bahrain,camp, Malegaon
Diploma in pharmacy, Pharmacy
2017 — 2019
Institute of Pharmaceutical Management
Postgraduate Diploma, Regulatory Affairs
Savitribai Phule Pune University
B.pharmacy, Pre-Pharmacy Studies
2019 — 2022
Mahatama Gandhi Vidyamandirs Samajshri Prashant Hiray College of Pharmacy,Malegaon Camp,Dist.Nashik 423101
B.pharmcy, B.pharmacy
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