Sudhir Baheti
Global Pharma Regulatory Affairs Specialist
- Role
- Associate Director Ii at Viatris
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Sudhir Baheti
A regulatory affairs professional with 15+ years experience spanning around global regulatory requirements, filing of marketing authorization applications and life cycle management. Key individual for delivering high value Complex Injectables & Ophthalmic products. Key contributor in setting up regulatory affairs department from scratch.
Experience
Associate Director Ii
Apr 2023 — Present · Bengaluru, IN
Education
Savitribai Phule Pune University
B. Pharm
2002 — 2006
Bharati Vidyapeeth
M. Pharm, Quality Assurance Techniques
2006 — 2008
Skills
- U.s. Food and Drug Administration (Fda)
- Pharmaceutics
- Regulatory Complaince
- Regulatory Affairs
- Ctd
- Electronic Common Technical Document (Ectd)
- Regulatory Submissions (Pre and Post Approval)
- Abbreviated New Drug Application (Anda)
- Dissolution
- Regulatory Requirements
- Anda
- Ectd
- Fda
- Regulatory Submissions
- Generic Programming
- Standard Operating Procedure (Sop)
- Validation
- Gmp
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