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Greg Smith

Director of Special Projects Staff at FDA's Center for Drug Evaluation and Research

Greg Smith is the Director of the India Office at the U.S. Food and Drug Administration (FDA), a position he assumed in August 2024. Prior to this role, he served as the Deputy Director of the FDA's India office, bringing over 13 years of experience with the FDA to his current position.12

Professional Background

  • Previous Roles: Before his appointment as Director, Smith led the Special Projects Staff at the Center for Drug Evaluation and Research (CDER), where he managed a multidisciplinary team addressing complex scientific, regulatory, and operational challenges. His earlier career includes significant positions in clinical research organizations, where he was involved in founding a Phase I clinical pharmacology center and overseeing late-phase clinical trials and risk evaluation strategies.123

  • Education and Certifications: Greg Smith holds a bachelor's degree in communications and public relations from the University of Maryland, College Park, and is certified in project and portfolio management.12

Current Focus

In his role as Director of the India Office, Smith is committed to enhancing the safety of medical products and food through collaborative efforts within the region. His expertise encompasses various aspects of regulatory affairs, including user-fee negotiations and supply chain assessments.12

Smith's extensive background in both regulatory science and clinical trial management positions him as a key figure in advancing FDA initiatives in India and beyond.

Highlights

Dec 20 · fda.gov
OII Field Leadership Contacts - FDA
Nov 15 · fda.gov
FDA Overseas Office Directors
FDA Overseas Office Directors
Aug 2 · expresspharma.in
Greg Smith appointed New Director of U.S. FDA India office
Greg Smith appointed New Director of U.S. FDA India office
Dec 11 · diaglobal.org
Speakers - Drug Information Association
Jan 1 · diaglobal.org
Speakers - Drug Information Association

Related Questions

What are Greg Smith's main responsibilities as the Director of the FDA India office?
How has Greg Smith's experience in clinical research organizations influenced his work at the FDA?
What specific projects has Greg Smith led in his role as Director of Special Projects Staff at FDA?
How did Greg Smith's role as Deputy Director prepare him for his current position as Director of the FDA India office?
What are some of the challenges Greg Smith has faced in his career at the FDA?
Greg Smith
Greg Smith, photo 1
Greg Smith, photo 2
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Location

Washington D.C. Metro Area