Prashant Wadekar
Senior Manager Regulatory Affairs
- Role
- Senior Manager Regulatory Affairs at G&L Scientific
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Prashant Wadekar
A pharmaceutical professional having 10+ years of proven skill-sets in driving various submissions to regulated, semi-regulated markets, achieving approvals, expanding exports & improving organizational profitability.Specialties · Has considerable expertise in the filling of Regulatory submission and has handled various market applications in EU region, South East Asian markets, African markets and WHO. Majorly worked for EU (eCTD/NeeS) generic markets.· Updated with latest developments with respect to submissions in CTD and eCTD format. · Possess a good level of computer skills. Has good communication, interpersonal, learning and organizing skills matched with the ability to manage stress, time and people effectively.
Experience
Senior Manager Regulatory Affairs
Mar 2023 — Present · Mumbai, IN
Education
University of Mumbai
B.Sc., Chemistry
2004 — 2005
Vasantidevi patil institute of Pharmacy
Diploma in Pharmacy, Pharmacy
2005 — 2007
Skills
- Dossier Preparation
- Maa
- Gmp
- Ectd
- Cmc
- Ctd
- Pharmaceutical Industry
- Sop
- Regulatory Affairs
- Regulatory Filings
- Regulatory Submissions
- Cmc Regulatory Affairs
- Regulatory Requirements
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