Kedar Pendharkar
Regulatory Affairs
- Role
- Manager Regulatory Affairs at Viatris
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
ScienceView LinkedIn profile
About Kedar Pendharkar
Experienced in Post registration activities of European – Post registration variations…
Experience
Manager Regulatory Affairs
Oct 2020 — Present
Education
I.P.E.R.Wardha,Maharashtra
B.Pharm, Pharmacy
2005 — 2009
L.B.S.Jr.Colllege Bhandara
HSC, Physics,chem,math
2004 — 2006
L.B.S.H.Bhandara
SSC, Science
2004 — 2005
Indian Institute of Technology, Bombay
Executive MBA
Washington University in St. Louis
Executive MBA
Nagpur University
M.Pharm, Pharmaceutics
2009 — 2011
Skills
- Technology Transfer
- Regulatory Submissions
- Ectd
- Abbreviated New Drug Application (Anda)
- Dissolution
- Pharmaceutics
- Regulatory Affairs
- Actd
- Pharmaceutical Research
- Validation
- Formulation
- Anda
- Ich Guidelines
- Dossier Preparation
- Common Technical Document (Ctd)
- Electronic Common Technical Document (Ectd)
- Capa
- Regulatory Requirements
- Ich-Gcp
- Generic Programming
- Pharmaceutical Industry
- Sop
- Fda
- Ctd
- Gmp
- Glp
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