FDA Public Health and Regulatory Research Fellowship

About the role

The Oak Ridge Institute for Science and Education (ORISE) Research Participation Programs at the U.S. Food and Drug Administration (FDA) offer students and recent graduates opportunities to participate in project-specific research and developmental activities at the Office of Commissioner (OC).

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.

Learning Objectives

• 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.
• Gaining knowledge of FDA's 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.
• 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

The anticipated appointment start date is November 1, 2026. Start date is flexible and will depend on a variety of factors. Appointment length is initially 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.

Qualifications

• The qualified candidate should be currently pursuing or have received a master's or doctoral degree in the relevant fields.
• Degree should be anticipated to receive by December 31, 2026.
• Preferred skills include experience in quantitative research methods, 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.