Smita Abbi
Executive Director, Regulatory Affairs, Therapeutic Area Lead forWomen’s Health at OrganonPresident, Vision Builders; a non-for profit focused on providing education, nutrition and healthcare to underserved people
- Role
- Executive Director at Organon
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Smita Abbi
24+ years of experience in the Pharmaceutical Industry spanning Translational /Clinical Sciences and Regulatory Affairs across all phases of drug development. Led Regulatory strategy for early development programs as well as late-stage drug development including management of post-approval marketed products. Expertise across several therapeutic areas including Neuroscience, Cardiovascular, Respiratory, Anti-infectives, Oncology and Women’s Health. I have experience in successfully navigation approvals for several INDs and NDA/BLA applications for small molecules and biologics. I have a keen understanding and passion for basic science.
Experience
Executive Director
Oct 2024 — Present · Jersey City, NJ, US
Education
Sri Venkateswara College, Delhi University
Bachelor of Science (BS), Biochemistry
1992 — 1995
Cornell University
Doctor of Philosophy (PhD), Molecular Medicine
1996 — 2001
Skills
- Immunology
- Infectious Diseases
- Clinical Research
- Clinical Pharmacology
- Oncology
- Regulatory Submissions
- Clinical Trials
- Pharmaceutical Industry
- Regulatory Affairs
- Gcp
- Ctms
- Biotechnology
- Clinical Development
- CRO
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