Ravi Harapanhalli
Senior Vice President Global Regulatory Affairs at Amneal Pharmaceuticals
- Role
- Senior Vice President Global Regulatory Affairs at Amneal Pharmaceuticals
- Location
- Silver Spring, MD, US
- LinkedIn followers
- 500 followers
General Business & ManagementView LinkedIn profile
About Ravi Harapanhalli
Fun loving individual with serious interests in the development and approval of…
Experience
Senior Vice President Global Regulatory Affairs
Jan 2016 — Present
Overseeing global regulatory affairs activities covering CMC, nonclinical, and clinical regulatory programs focusing on generics, and 505B2 products.
Education
University of Medicine and Dentistry of New Jersey
Postdoctoral Fellowship
1989 — 1994
Harvard Medical School
Radiopharmaceuticals
1994 — 1997
Indian Instutute of Technology, Bombay
Doctor of Philosophy (Ph.D.)
1980 — 1986
Skills
- Gmps
- Change Control
- Radiopharmaceuticals
- CRO
- Commercialization
- Radiochemistry
- Analytical Chemistry
- Regulatory Affairs
- Gmp
- Validation
- Science
- Oncology
- Maa
- Ind
- Regulatory Submissions
- Glp
- Leadership
- Pharmaceutical Industry
- Sop
- Fda
- Drug Delivery
- Fda Gmp
- Sop Development
- Toxicology
- Process Validation
- Quality Assurance
- Pma
- Life Sciences
- R&D
- Clinical Development
- Hplc
- Quality System
- Regulatory Compliance
- Process Simulation
- Biosimilars
- Drug Development
- Gcp
- Biopharmaceuticals
- Biotechnology
- Product Development
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