Sanjay K Rangadhol
Senior Pharmaceutical Scientist | 25+ Years Driving Product Development, Tech Transfer & Manufacturing Excellence | Oral Solids, Parenterals, Softgels, Liquids & Semisolids
- Role
- Vice President, R & d and Regulatory at Qualigens Pharma Private Limited
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Sanjay K Rangadhol
Senior Pharmaceutical professional with 25+ years of international experience across drug development, technology transfer, scale-up, validation and regulatory CMC. Extensive exposure to USFDA, EMA, MHRA and ROW markets, with a strong track record of delivering complex products from concept to commercialization.Known for strategic leadership, risk-based decision making, and building cross-functional, high-performing teams across geographies.
Experience
Vice President, R & d and Regulatory
Qualigens Pharma Private Limited
Aug 2022 — Present · Navi Mumbai, IN
Leading R&D, technology transfer and regulatory CMC activities for oral solid dosage forms.Managing site transfers and new product introductions for Europe and South Africa.Performing technical risk assessments and gap analyses for transferred products.Ensuring readiness and compliance of validation protocols, reports and supporting documents.Executing validation batches within committed timelines and compiling technical dossiers.Authoring and responding to regulatory authority queries, enabling timely approvals.
Education
NATIONAL COLLEGE OF PHARMACY
Bachelor of Pharmacy, Pharmaceutical Sciences
JSS Academy of Higher Education & Research
Masters of Pharmacy, Industrial Pharmacy
1996 — 1998
JSS College of Pharmacy, Mysuru (Official Page)
Master's Degree, Industrial and Physical Pharmacy and Cosmetic Sciences
Kuvempu University, Shankaraghatta, Shimoga
Bachelors of Pharmacy, Pharmaceutical Sciences
Skills
- Formulation
- Technology Transfer
- Generic Programming
- Product Development
- Drug Delivery
- Validation
- Pharmaceutics
- Pharmaceutical Research
- Gmp
- Regulatory Affairs
- Pharmaceutical Industry
- R&D
- Anda
- Drug Development
- Glp
- Pharmacokinetics
- Dissolution
- Fda
- Quality by Design
- Regulatory Submissions
- Abbreviated New Drug Application (Anda)
- Research and Development (R
- U.s. Food and Drug Administration (Fda)
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