Ganesh Lende
Regulatory Affairs Sr.Specialist
- Role
- Regulatory Affairs Sr Specialist at MSD
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
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About Ganesh Lende
I have more than 12 years of wide experience in Product registration, Renewal, CMC…
Experience
Regulatory Affairs Sr Specialist
May 2017 — Present · Mumbai, IN
Responsible for management of various regulatory projects on- Change assessment Variations Remediation Strategy Regulatory Intelligence database maintenance
Education
University of Mumbai
Bachelor of Pharmacy
2001 — 2004
Maharashtra state board of technical education (MSBTE) Mumbai
Diploma in Pharmacy
2001
Skills
- Pharmaceutical Industry
- Sop
- Fda
- Ich-Gcp
- Pharmaceutics
- Generics
- Regulatory Submissions
- Clinical Trials
- Biotechnology
- Validation
- CRO
- Regulatory Requirements
- Regulatory Affairs
- Lifesciences
- 21 Cfr Part 11
- Change Control
- Generic Programming
- Standard Operating Procedure (Sop)
- Pharmacovigilance
- Gmp
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