Ashokk Suthar
Regulatory Affairs Professional | 15+ Years of Global Expertise | Strategic CMC & Lifecycle Management | RA Compliance | Ex-Amneal, Sandoz, Zydan, Cipla, Micro
- Role
- Senior Manager (Team Lead) at Cosette Pharmaceuticals, Inc.
- Location
- Navi Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Ashokk Suthar
I am a seasoned Regulatory Affairs professional with over 16 years of experience in…
Experience
Senior Manager (Team Lead)
Nov 2024 — Present · Navi Mumbai, IN
Led the Regulatory team at Cosette Pharma Inc. in Navi Mumbai, ensuring accurate and timely regulatory submissions, compliance management, and project strategy alignment- Coordinated and reviewed various regulatory submissions, including original ANDAs/NDAs, supplements, and PADERs/annual reports- Maintained strict compliance with post-approval regulatory filing deadlines and collaborated with cross-functional teams to align project strategies- Managed labelling maintenance, project timelines, and change evaluations, contributing to the company\'s success in the pharmaceutical industry.
Education
Saurashtra University, Rajkot
Bachelor's degree
2002 — 2006
Lachoo Memorial College of Science & Tech
Master's degree
2006 — 2008
Skills
- Pharmaceutical Research
- Validation
- Pharmaceutics
- Analytical Chemistry
- Ich Guidelines
- Regulatory Affairs
- Electronic Common Technical Document (Ectd)
- Gmp
- Cleaning Validation
- Pharmaceutical Industry
- Sop
- Fda
- Annual Reports
- U.s. Food and Drug Administration (Fda)
- South Africa
- Glp
- Variation
- Technology Transfer
- Qbd
- Ectd
- Change Control
- Regulatory Submissions
- Supplements
- Hplc
- Regulatory Requirements
- Formulation
- Gwi
- Quality Assurance
- Amendment
- Abbreviated New Drug Application (Anda)
- Dissolution
- Generic Programming
- Standard Operating Procedure (Sop)
- Pmda
- Good Laboratory Practice (Glp)
- Anda
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.