Prasad Tandale
Senior Specialist | Regulatory Medical Writing | Clinical Development | Women\'s Health, Oncology, Immunology | 17+ Yrs Pharma Experience
- Role
- Senior Specialist & Asset Lead, Regulatory Medical Writing at Organon
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Prasad Tandale
With over 18 years of progressive experience in regulatory medical writing and clinical…
Experience
Senior Specialist & Asset Lead, Regulatory Medical Writing
Aug 2024 — Present · IN
Lead author and strategic owner for global regulatory documents across women’s health portfolio- Oversee end-to-end clinical writing for CSRs, protocols, CTDs, and agency responses- Drive collaboration across clinical, regulatory, and biometrics functions
Education
Rajiv Gandhi University of Health Sciences
Master of pharmacy
2001 — 2003
Sainik School Satara
Secondary School Certificate
1989 — 1995
Maharashtra College of Pharmacy
Bachelor of Pharmacy (B.Pharm.)
1997 — 2001
SunRise University Alwar
Doctor of Philosophy - PhD
2018 — 2023
Skills
- Pharmaceutical Industry
- Pharmaceutics
- Regulatory Affairs
- Sop
- Clinical Trials
- Pharmacology
- Drug Delivery
- Pharmacovigilance
- Lifesciences
- Biotechnology
- Formulation
- Pharmacokinetics
- Gcp
- Drug Discovery
- Clinical Research
- Ich-Gcp
- Technology Transfer
- Gmp
- Regulatory Requirements
- Life Sciences
- Good Clinical Practice (Gcp)
- Standard Operating Procedure (Sop)
- Regulatory Submissions
- Clinical Development
- U.s. Food and Drug Administration (Fda)
- Medical Writing
- Protocol
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