FDA Public Health and Regulatory Research Fellowship
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A complete application consists of:
- An application
- Transcripts – Click here for detailed information about acceptable transcripts
- A current resume/CV, including academic history, employment history, relevant experiences, and publication list
- Two educational or professional recommendation
All documents must be in English or include an official English translation.
If you have questions, send an email to ORISE.FDA.OC.other@orau.org. Please include the reference code for this opportunity in your email.
*Applications will be reviewed on a rolling-basis.
FDA Office and Location: A research opportunity is available immediately with the Food and Drug Administration (FDA), Office of Commissioner (OC), Public Health Strategy and Analysis Staff (PHSA) located in Silver Spring, Maryland.
The Oak Ridge Institute for Science and Education (ORISE) Research Participation Programs at the U.S. Food and Drug Administration are educational and training programs designed to provide students and recent graduates, opportunities to participate in project-specific research and developmental activities at the Office of Commissioner (OC). OC provides policy making, program direction, coordination, liaison, and expert advice to agency leadership and programs in support of FDA's science-based regulatory work.
Research Project: You will participate in research and analytical activities involving FDA's domestic and global regulatory science mission. You will gain hands-on experience at the intersection of public health policy, epidemiology, and regulatory science, while engaging in FDA's efforts to protect and promote public health both domestically and globally. Fellowship activities are organized across three interconnected project areas, each offering structured training and learning experiences.
Project 1: Drug Competition and Access
- Developing understanding of FDA drug approval programs, including generic and biosimilar pathways, and their role in medicine access and affordability.
- Building skills in analyzing regulatory, epidemiologic, and market data related to drug competition and availability.
- Understanding how regulatory science and policy considerations influence public health outcomes and patient access to safe and effective medicines.
Project 2: FDA Regulatory Pathways
- Gaining knowledge of FDA regulatory pathways, including expedited programs and novel approval mechanisms, and their public health objectives.
- Strengthening analytical skills through evaluation of pathway utilization data and associated public health outcomes.
- Exploring how regulatory evidence and policy analysis contribute to Agency decision-making and public health priorities.
Project 3: Global Health
- Developing understanding of FDA’s role in global public health and international regulatory collaboration.
- Building skills in analyzing global drug quality issues, cross-border regulatory challenges, and international health data.
- Enhancing scientific communication abilities through research, drafting, and contribution to policy-relevant and scientific publications on global health topics.
Mentor: The mentor can be reached at ophsa@fda.hhs.gov. If you have questions about the nature of the research, please contact the mentor.
Anticipated Appointment Start Date: November 1, 2026. Start date is flexible and will depend on a variety of factors.
Appointment Length: The appointment will initially be for 12 months, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.
Level of Participation: The appointment is full time.
Participant Stipend: The participant will receive a monthly stipend commensurate with educational level and experience. The anticipated stipend is $7,600 per month, plus $532 per month for a health insurance supplement.
Citizenship Requirements: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.
This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment-related benefits.
Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on-boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.
The qualified candidate should be currently pursuing or have received a master's or doctoral degree in the one of the relevant fields. Degree should be anticipated to receive by 12/31/2026.
Preferred skills:
- Experience in quantitative research methods, including but not limited to epidemiological analysis, secondary data analysis, or statistical modeling.
- Strong scientific writing skills and demonstrated ability to communicate complex findings to diverse audiences.
- Demonstrated ability to research both independently and collaboratively in a team environment.
I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)
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