Vikram Shitole
Manager Regulatory Affairs - Global CMC
- Role
- Regulatory Affairs Manager at G&L Scientific
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Vikram Shitole
Regulatory professional with 6 plus years of experience on Initial as well as post approval CMC change submissions to regulatory authorities by achieving deadlines. Demonstrated exceptional projects leading, strategic problem solving and communication skills. Gained vital international exposure while working and studying in UK. Compiled and reviewed CMC part of dossiers (Module 1, 2 & 3) for Europe, Australia, Canada and ROW Markets, Variations (Type I and II) and renewal submissions for EU and ROW markets in eCTD format. Prepared and reviewed Query responses to regulatory authorities for Initial, Variation and renewal submissions. Possessing confidence and more enthusiasm to acquire necessary skills in new areas and self‐ motivation to work reliably with independence or as a respected team member, highly self‐ motivated with the ability and fo
Experience
Regulatory Affairs Manager
Nov 2022 — Present · Mumbai, IN
Education
London Metropolitan University, London, United Kingdom.
Masters, Pharmaceutical sciences
2009 — 2010
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