Sanjay Thorat
Regulatory Affairs Manager at Abbott Healthcare Pvt Ltd - India
- Role
- Regulatory Affairs Manager at Abbott
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Sanjay Thorat
I have initiated my pharmaceutical career in March-2005 as officer in Analytical Method…
Experience
Regulatory Affairs Manager
May 2020 — Present · Mumbai, IN
Managing multiple activities according to agreed timelines and deliverablesActing as the CMC subject matter expert in cross-functional project teamsUtilising technical and regulatory knowledge and acumen to drive projectsEvaluating, interpreting, simplifying and communicating complex situations and dataEvaluating and interpreting legislation and regulatory intelligence and its business impactGenerating innovative and robust CMC regulatory strategiesIdentifying and evaluating regulatory risks and providing mitigation plans Identifying and executing process improvement initiativesProviding mentoring and coaching support and guidance to more junior colleaguesWriting and compiling high-quality right-first-time submission-ready CMC documentationLiaising with colleagues across multiple time zones and cultures
Education
Institute of Pharmaceutical Management.
Post Graduation Diploma in Regulatory Affairs- Formulation & API, Regulatory Affairs
2009 — 2009
University of Mumbai
Master of Science (M.Sc.), Inorganic Chemistry
2002 — 2004
Skills
- Anda
- Pharmaceutical Industry
- Fda
- Ectd
- Regulatory Submissions
- Hplc
- Regulatory Filings
- Regulatory Requirements
- Analytical Chemistry
- Validation
- Regulatory Affairs
- Cmc Regulatory Affairs
- Ctd
- Cmc
- Abbreviated New Drug Application (Anda)
- Dissolution
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