Prasad Vaishampayan
Regulatory Specialist, 20 years of work experience. Ex Alkem AGM, Ex Abbott,New Drugs, Biosimilars, Reference Biological drug products, Import registration, Cosmetics. Clinical trials, vaccines.
- Role
- Head of Regulatory Affairs at Sanofi
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Prasad Vaishampayan
Pharmaceutical professional with clinical and regulatory expertise.Regulatory affairs work, India & Nepal at Alkem Labs. Also worked in Getz Pharma Research for the NOC for form 29 for new drugs, test license approvals in form 29 from state licensing authority, Export NOC, Import of RLD and API in form 11, BE NOC permissions, facility approvals, DSIR registration and recognitionScaled up and attained expertise in my profession of clinical research. Worked on conduct of 505 b 2 category of products for U.S. FDA submission.Extensively monitored phase 2 and 3, global protocols for the indications of diabetes, pediatric bronchial asthma, cardiology, dermatology & nephrology.Worked on project mangement of dermatology studies in US and Europe regions for Glenmark - Generics - as ANDA submission to USFDA. 2 studies have qualified the FDA standards.Complete domestic Product Development for Indian Drug Regulatory Submission including bulk drug permissions. Protocol writing, BE study NOC, BE protocol writing and conduct. SOP development and writing, documentation of prescribing information and product inserts, new drug approvals from DCGI.Specialties: Specialization in Pharmacy and Pharmaceutical Management, Life sciences Knowledge. Complete understanding of conduct of a clinical trial in India & Nepal.
Experience
Head of Regulatory Affairs
Feb 2026 — Present · IN
Regulatory affairs role for Vaccine division
Education
SIES college of Mangement studies
Post Graduate Diploma, Pharmaceutical Management
2004 — 2006
Manjunatha Vidyalaya
S.S.C., Secondary school certificate
1985 — 1997
University of Mumbai
Bachelors in Pharmacy, Pharmaceutical and Life sciences
1999 — 2003
Skills
- Clinical Study Design
- Clinical Development
- Regulatory Submissions
- Oracle Clinical
- Regulatory Affairs
- Lifesciences
- Domestic Product Registration
- Ich-Gcp
- Drug Development
- Gcp
- Clinical Trials
- Clinical Research
- Product Development
- Dermatology
- Sop
- Fda
- Trial Management
- Edc
- Protocol
- Crf Design
- Clinical Monitoring
- Pharmacokinetics
- Diabetes
- Clinical Operations
- Pharmacovigilance
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