Pravin Gore
Regulatory Affairs (Biotech) - Global Markets
- Role
- Senior Executive at Lupin
- Location
- Gurugram, HR, IN
- LinkedIn followers
- 500 followers
Experience
Senior Executive
Nov 2024 — Present · Pune, IN
Regulatory Affairs (Biotech)- Global Markets. Dossier preparation and submission of NDA, BLA and MAA to various regulatory authorities across the world. Post approval changes, response to queries. Review and approve technical and scientific documents being generated at R&D and commercial manufacturing facility. Regulatory impact analysis of the change control, communication with customer for notification and approval as applicable. Project discussion with R&D, Business development, Commercial manufacturing. Involved in technical discussion related to changes impacting submission in various geographies.Labelling and eCTD Publishing activities.eCTD Softwares: PharmaReady and Educe.
Education
University Department of Pharmaceutical Sciences, RTM University, Nagpur
Bachelor of Pharmacy
2013 — 2017
Adarsh College, Hingoli
12th
2011 — 2013
Indian Institute of Technology (Banaras Hindu University), Varanasi
Master of Pharmacy
2017 — 2019
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