Regulatory Pharmaceutical Fellowship Program
The U.S. Food and Drug Administration (FDA) partners with universities and colleges of pharmacy in the United States to offer FDA-affiliated fellowship programs to Doctor of Pharmacy graduates in several specialties. The purpose of the Regulatory Pharmaceutical Fellowship program is to train selected candidates in one of six tracks focused on drug information, medication safety, regulatory advertising & promotion, regulatory affairs and policy, biopharmaceutical manufacturing, or regulatory science. The program provides participants with the unique opportunity to learn from mentors in their chosen specialty track across three diverse settings in government, academia, and industry. Graduates of the fellowship program are qualified to pursue careers in any of the three practice settings.
Recruitment is closed for 2023-2025 positions.
Program specific information, important dates, and links to more information about available 2024-2026 opportunities will be made available in October 2023.
Biopharmaceutical Manufacturing – 1 position
Two-Year Biopharmaceutical Manufacturing Fellowship provided by Albany College of Pharmacy and Health Sciences
Fellowship dates: July 1, 2023 – June 30, 2025
- Four months will be spent with the Stack Family Center for Biopharmaceutical Education and Training (CBET) at Albany College of Pharmacy and Health Sciences in Albany, NY
- Twelve months will be spent at Curia Global in global contract research, development and manufacturing at one or more locations
- Eight months will be spent at FDA in the Office of Pharmaceutical Manufacturing Assessment in the Office of Pharmaceutical Quality in Silver Spring, MD
Visit Albany College of Pharmacy CBET Fellowship Program Website for eligibility criteria and key application dates. Questions? Contact Diana.Bartlett@acphs.edu.
Drug Advertising and Promotion - 1 position
Two-Year Regulatory Advertising and Promotion Fellowship provided by Purdue University
Fellowship dates: July 1, 2023 - June 30, 2025
- Six months will be spent at Purdue University in Indianapolis, IN
- Nine months will be spent at Johnson & Johnson in Titusville, NJ
- Nine months will be spent at FDA in the Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research in Silver Spring, MD (currently a remote work environment)
Visit Purdue University's Regulatory Advertising and Promotion Fellowship Website for eligibility criteria and key application dates. Questions? Contact AdPromoFellowship@purdue.edu
Drug Information – 1 position
Two-Year Drug Information Fellowship provided by Belmont University
Fellowship dates: June 1, 2023 – May 31, 2025
- Six months will be spent at Belmont University in the Christy Houston Foundation Drug Information Center in Nashville, TN
- Twelve months will be spent at Aegis Sciences Corporation on the Clinical Pharmacist team in Nashville, TN (currently a remote work environment)
- Six months will be spent at FDA in the Division of Drug Information in the Center for Drug Evaluation and Research in Silver Spring, MD
Visit Belmont University's Drug Information Fellowship Website for eligibility criteria and key application dates. Questions? Contact druginfo@belmont.edu.
Drug Information – 2 positions
Two-Year Drug Information Fellowship provided by Purdue University
Fellowship dates: July 1, 2023 – June 30, 2025
- Six months will be spent at Purdue University in Indianapolis, IN
- Twelve months will be spent at Eli Lilly & Company in Global Medical Information in Indianapolis, IN or at Janssen Scientific Affairs, LLC in Medical Information in Titusville, NJ
- Six months will be spent at FDA in the Division of Drug Information in the Center for Drug Evaluation and Research in Silver Spring, MD
Visit Purdue University's Drug Information Fellowship Website for eligibility criteria and key application dates. Questions? Contact DrugInfoFellowship@purdue.edu
Medication Safety – 1 position
Two-Year Medication Error Pharmacovigilance and Risk Management Fellowship provided by Butler University
Fellowship dates: July 1, 2023 – June 30, 2025
- Four months will be spent at Butler University in Indianapolis, IN
- Twelve months will be spent at Regeneron Pharmaceuticals in Regulatory Affairs and Global Patient Safety in Tarrytown, NY
- Eight months will be spent at FDA in the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology in Silver Spring, MD
Visit Butler University's Pharmacy Fellowship Programs Website for eligibility criteria and key application dates. Questions? Contact rxfellowships@butler.edu
Medication Safety – 1 position
Two-Year Global Patient Safety and Pharmacovigilance Fellowship provided by Butler University
Fellowship dates: July 1, 2023 – June 30, 2025
- Four months will be spent at Butler University in Indianapolis, IN
- Twelve months will be spent at Eli Lilly in Global Patient Safety in Indianapolis, IN
- Eight months will be spent at FDA in the Division of Medication Error Prevention and Analysis in the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology in Silver Spring, MD
Visit Butler University's Pharmacy Fellowship Programs Website for eligibility criteria and key application dates. Questions? Contact rxfellowships@butler.edu
Medication Safety – 1 position
Two-Year Medication Safety Fellowship provided by Purdue University
Fellowship dates: July 1, 2023 – June 30, 2025
- Four months will be spent at Purdue University in West Lafayette, IN
- Twelve months will be spent at AbbVie in Pharmacovigilance and Patient Safety in North Chicago, IL
- Eight months will be spent at FDA in the Division of Risk Management in the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology in Silver Spring, MD
Visit Purdue University's Medication Safety Fellowship for eligibility criteria and key application dates. Questions? Contact MedSafetyFellowship@purdue.edu
Medication Safety – 1 position
Two-Year Risk Management Fellowship provided by Rutgers University
Fellowship dates: July 1, 2023 – June 30, 2025
- A longitudinal academic experience will be provided by Rutgers University in Piscataway, NJ with travel expected to the campus at least once monthly throughout the program
- Twelve months will be spent at Pfizer in the Risk Management Center of Excellence in Collegeville, PA
- Twelve months will be spent at FDA the Division of Risk Mitigation Assessment and Medication Error Surveillance, in the Office of Medication Error Prevention and Risk Management in the Office of Surveillance and Epidemiology in Silver Spring, MD
Visit Rutgers Pharmaceutical Industry Fellowship Program for eligibility criteria and key application dates. Questions? Contact Carolyn.Seyss@pharmacy.rutgers.edu
Regulatory Policy and Program Management – 2 positions
Two-Year Regulatory Policy and Program Management Fellowship provided by Howard University
Fellowship dates: July 1, 2023 – June 30, 2025
- A longitudinal academic experience will be provided by Howard University in Washington, DC with travel expected to campus for predetermined instruction and development focused on the drug development process and its requisite policy
- Eighteen months will be spent at Genentech in a rotational immersion in regulatory policy and program management in Washington, DC (travel expected as needed to the San Francisco Headquarters)
- Six months will be spent at FDA in the Office of Medical Policy in Silver Spring, MD
Visit Howard University College of Pharmacy Fellowship Programs Website External Link Disclaimer for eligibility criteria and key application dates. Questions? Contact Earl.Ettienne@Howard.edu
Global Regulatory Affairs and Policy – 2 positions
Two-Year Regulatory Affairs and Policy Fellowship provided by Howard University
Fellowship dates: July 1, 2023 – June 30, 2025
- Six-month longitudinal academic experience will be provided at Howard University in Washington, DC with an emphasis on mastering research design and methodology, and understanding legislation and regulation. Fellows will have an opportunity to earn certificates in Teaching, Regulatory Writing, and Regulatory Affairs (RAC).
- Twelve months will be spent at GlaxoSmithKline in a rotational immersion in regulatory advertising and promotion, strategy, and policy and intelligence.
- Six months will be spent at FDA in the Office of Medical Policy in Silver Spring, MD focused in either patient labeling or regulatory policy
Visit Howard University College of Pharmacy Fellowship Programs Website External Link Disclaimer for eligibility criteria and key application dates. Questions? Contact Earl.Ettienne@Howard.edu
Regulatory Science – 1 position
Two-Year Regulatory Science Fellowship provided by Rutgers University
Fellowship dates: July 1, 2023 – June 30, 2025
- Eight months will be spent in a clinical rotation experience, provided by Rutgers University Ernest Mario School of Pharmacy in Piscataway, NJ at an associated clinical practice site
- Eight months will be spent at Sanofi in regulatory strategy exposure in the Regulatory Affairs North American organization in Bridgewater, NJ (travel expected as needed to the site)
- Eight months will be spent at FDA in the Division of Pediatrics and Maternal Health in the Office of New Drugs in Silver Spring, MD
Visit Rutgers Pharmaceutical Industry Fellowship Program Website for eligibility criteria and key application dates. Questions? Contact Carolyn.Seyss@pharmacy.rutgers.edu
For questions about FDA-Affiliated Pharmacy Fellowship Programs that cannot be addressed directly to a specific program above, contact FDA’s Division of Drug Information at pharmacy.fellowships@fda.hhs.gov.