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 2024-2026 positions.
Program specific information, important dates, and links to more information about available 2025-2027 opportunities will be made available in October 2024.
Biopharmaceutical Manufacturing
Two-Year Biopharmaceutical Manufacturing Fellowship provided by Albany College of Pharmacy and Health Sciences
Fellowship dates: TBD, typical timeline shown below.
- Four months with the Stack Family Center for Biopharmaceutical Education and Training (CBET) at Albany College of Pharmacy and Health Sciences in Albany, NY
- Twelve months at Curia Global in global contract research, development and manufacturing at one or more locations
- Eight months at FDA in the Office of Pharmaceutical Manufacturing Assessment in the Office of Pharmaceutical Quality in Silver Spring, MD
Questions? Contact Bernard.Tyrrell@acphs.edu.
Drug Advertising and Promotion
Two-Year Regulatory Advertising and Promotion Fellowship provided by Purdue University
Fellowship dates: TBD, typical timeline shown below.
- Six months at Purdue University in Indianapolis, IN
- Nine months at Johnson & Johnson in Titusville, NJ
- Nine months 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)
Questions? Contact AdPromoFellowship@purdue.edu
Drug Information
Two-Year Drug Information Fellowship provided by Belmont University
Fellowship dates: TBD, typical timeline shown below.
- Seven months will be spent at Belmont University with practice site responsibilities in the HealthTrust Drug Information Service in Nashville, TN
- Six months will be spent at Belmont University in the Christy Houston Foundation Drug Information Center in Nashville, TN
- Five months will be spent at HealthTrust GPO Operations in Nashville, TN
- 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
Two-Year Drug Information Fellowship provided by Purdue University
Fellowship dates: TBD, typical timeline shown below.
- 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 Horsham, PA
- 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
Two-Year Pharmacovigilance Fellowship provided by Albany College of Pharmacy and Health Sciences
Fellowship dates: TBD, typical timeline shown below.
- Six months will be spent at Albany College of Pharmacy and Health Sciences in Albany, NY
- Nine months will be spent remotely at BeiGene in Global Patient Safety
- Nine months will be spent at FDA with Regulatory Science Staff in the Office of Surveillance and Epidemiology in Silver Spring, MD
Visit Albany College of Pharmacy and Health Sciences Fellowship Opportunities for eligibility criteria and key application dates. Questions? Contact patrick.meek@acphs.edu
Medication Safety
Two-Year Medication Error Pharmacovigilance and Risk Management Fellowship provided by Butler University
Fellowship dates: TBD, typical timeline shown below.
- 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
Two-Year Global Patient Safety and Pharmacovigilance Fellowship provided by Butler University
Fellowship dates: TBD, typical timeline shown below.
- 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
Two-Year Medication Safety Fellowship provided by Purdue University
Fellowship dates: TBD, typical timeline shown below.
- Four months will be spent at Purdue University in Indianapolis, 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
Two-Year Risk Management Fellowship provided by Rutgers University
Fellowship dates: TBD, typical timeline shown below.
- A longitudinal academic experience provided by Rutgers University in Piscataway, NJ with travel expected to the campus at least once monthly throughout the program
- Twelve months at Pfizer in the Risk Management Center of Excellence in Collegeville, PA
- Twelve months 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
Questions? Contact Carolyn.Seyss@pharmacy.rutgers.edu
Regulatory Policy and Program Management
Two-Year Regulatory Policy and Program Management Fellowship provided by Howard University
Fellowship dates: TBD, typical timeline shown below.
- A longitudinal academic experience 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 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 at FDA in the Office of Medical Policy in Silver Spring, MD
Questions? Contact Earl.Ettienne@Howard.edu
Global Regulatory Affairs and Policy
Two-Year Regulatory Affairs and Policy Fellowship provided by Howard University
Fellowship dates: TBD, typical timeline shown below.
- Six-month longitudinal academic experience 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 at GlaxoSmithKline in a rotational immersion in regulatory advertising and promotion, strategy, and policy and intelligence.
- Six months at FDA in the Office of Medical Policy in Silver Spring, MD focused in either patient labeling or regulatory policy
Questions? Contact Earl.Ettienne@Howard.edu
Regulatory Science
Two-Year Regulatory Science Fellowship provided by Rutgers University
Fellowship dates: TBD, typical timeline shown below.
- 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
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.