Harsh Sakre
Associate Drug Regulatory Affairs
- Role
- Associate at Zim Laboratories Limited
- Location
- Nagpur, IN
- LinkedIn followers
- 500 followers
About Harsh Sakre
As a Drug Regulatory Affairs professional, my objective is to leverage my expertise in…
Experience
Associate
Nov 2023 — Present · Nagpur, IN
Regulatory Affairs Professional | Global Expertise in CMC Dossier Preparation and Regulatory SubmissionsDedicated and detail-oriented Regulatory Affairs Professional with over 2 years of experience driving global regulatory compliance and ensuring successful market access for pharmaceutical products. Specializing in CMC dossier preparation, eCTD/CTD/ACTD authoring, and managing regulatory filings across diverse regions, including the EU, ASEAN, LATAM, and Africa.Proven track record in streamlining submission processes, ensuring adherence to international guidelines (ICH, EMA, FDA, TGA), and collaborating with cross-functional teams to facilitate timely approvals. Skilled in regulatory documentation, artwork review, query management, and leveraging advanced eCTD tools like Educe and Lorenzo to meet tight deadlines without compromising accuracy.
Education
University Institute of Technology, RGPV
Master of Pharmacy
2019 — 2021
University Institute of Technology, RGPV
Bachelor of Pharmacy - BPharm
2014 — 2018
Maharshi vidhya mandir, balaghat (M.P)
B.Pharm
2014 — 2018
VNS Group of Institution,VNS Campus, Vidya Vihar, Nathu Barkheda, Neelbud, Bhopal-462044
M.Pharm (Pharmaceutics)
2019 — 2021
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