Paramita Mookherjee
Director, Toxicology at Regeneron
- Role
- Director at Regeneron
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Paramita Mookherjee
HIGHLIGHTS OF DRUG DEVELOPMENT AND SAFETY ASSESSMENT EXPERIENCE:• Experience conducting nonclinical risk assessment of drug development candidates for both oncology and non-oncology indications (GLP and non-GLP)• Knowledge of small molecule and large molecule (biologic) drug development strategies and ICH guidelines• Experience with the design, implementation and management of regulatory toxicology packages for worldwide submissions• Authored the nonclinical section of an NDA for a small molecule kinase inhibitor treating mantle cell lymphoma patients which had FDA breakthrough designation and accelerated marketing approval• Authored the nonclinical sections of submissions to regulatory agencies (US-FDA and ex-US) for large molecule (biologic) non-oncology drug candidates in first-in-human (FIH) clinical trials
Experience
Director
Feb 2024 — Present
Education
Tennessee Technological University
MS, Chemistry
1996 — 1998
University of Alabama at Birmingham
PhD, Cell Biology
2006
Vanderbilt University
BS, Chemistry
1992 — 1996
Skills
- Cell
- Drug Discovery
- Elisa
- Regulatory Filings
- Glp
- Project Management
- Cell Based Assays
- Pharmacology
- Cell Culture
- In Vitro
- Risk Assessment
- Ich-Gcp
- Preclinical Drug Development
- Molecular Biology
- Drug Development
- Ich Guidelines
- Biopharmaceuticals
- Biotechnology
- Predictive Toxicology
- Neuroscience
- Nda
- Oncology
- Regulatory Submissions
- In Vivo
- Regulatory Requirements
- Ind
- Science
- Nonclinical Drug Development
- Safety Pharmacology
- Life Sciences
- Bla
- Assay Development
- Regulatory Guidelines
- Cell Biology
- Purification
- Good Laboratory Practice (Glp)
- Alzheimer's Disease
- Dart
- Biologics
- Pharmaceutical Industry
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