Saryu Goel
Senior Pharmacology/Toxicology Reviewer, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine
- Role
- Senior Pharmacology Toxicology Reviewer at FDA
- Location
- Silver Spring, MD, US
- LinkedIn followers
- 500 followers
About Saryu Goel
Specialties: Pharmacology/Toxicology Educator, Public Speaking, Competitive Intelligence, Regulatory Affairs, Translational Research, Toxicology, Immunology, Veterinary Reproduction, Veterinary Medicine, Quantitative/Qualitative Structure Activity Relationship [(Q)SAR], Genotoxic Impurity Risk Assessment and Mitigation, Safety Assessment of Biologics, Pharmaceuticals, Nutraceuticals, Good Laboratory Practice (GLP), Good Clinical Practice (GCP).
Experience
Senior Pharmacology Toxicology Reviewer
Oct 2017 — Present · Silver Spring, MD, US
Provide expert advice to representatives of pharmaceutical companies on proposed nonclinical and regulatory drug development strategy for successful submissions. Perform expert safety reviews of nonclinical submissions during drug development from preIND, IND, through NDA/BLA & post marketing. Expert in reviews of toxicology studies for new drugs (small molecules, large-molecules, including impurities, residual solvents, excipients, flavors, fragrances, extractables & leachables, etc.).
Education
Auburn University
PhD, Toxicology & Environmental Science
1993 — 1996
University of Ibadan
DVM, Veterinary Medicine
1983 — 1988
Regulatory Affairs Professional Society
Regulatory Affairs Certificate (RAC), USA, US Regulatory Affairs
2005 — 2007
Tuskegee University
MS, Immunology
1992 — 1993
University of Ibadan
MVSc, Veterinary Obstetrics and Gynecology
1988 — 1990
University of Michigan
Research Fellow/Adjunct Lecturer, Reproductive Toxiciology
1997 — 2000
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