FDA Public Health and Regulatory Research Fellowship

Overview

*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) located in White Oak, 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 supporting FDA’s domestic and global regulatory science mission. You will gain hands-on experience at the intersection of public health policy, regulatory science, and international affairs, while contributing to FDA’s efforts to protect and promote public health both domestically and globally.

Project 1: Substandard and Falsified Medical Products (SFMPs)You will participate in research investigating substandard and falsified medical products, a global public health threat. Activities will include analyzing global flows of substandard and falsified medicines, investigating supply chain vulnerabilities, and contributing to the development of strategies and international partnerships aimed at combating SFMPs. You will also collaborate with mentors to research, draft, and contribute to scientific papers and policy-relevant publications on this topic.
Project 2: Research Supporting Foreign Office OperationsYou will contribute to research supporting FDA’s international office operations, with a focus on analyzing data and findings related to unannounced inspections of foreign drug manufacturers. Through this, you will investigate inspection outcomes and trends, helping to inform FDA’s global regulatory oversight strategies and strengthen the agency’s ability to ensure the safety and quality of imported medical products.
Project 3: Artificial Intelligence Integration in FDA Research and OperationsYou will collaborate with mentors to research and help design strategies for integrating artificial intelligence (AI) tools into FDA’s regulatory research projects, including applications relevant to foreign post operations and inspections. You will investigate emerging AI methodologies, analyze their potential applications in a regulatory context, and contribute to developing frameworks that advance FDA’s capacity to leverage cutting-edge technology in support of its public health mission.
Project 4: Generic Drug Approval Programs and Market CompetitionYou will participate in research examining FDA’s generic drug approval programs, with the goal of developing a deeper understanding of generic drug development pathways and market competition dynamics. You will analyze relevant data and regulatory frameworks to contribute insights that can inform FDA policies aimed at improving access to safe, effective, and affordable generic medicines for American consumers.
Learning Objectives: Throughout the fellowship, you will engage in structured learning opportunities designed to build experience in regulatory science, global health policy, and data analysis. These include mentored research experiences with FDA subject matter experts, participation in relevant training programs and seminars, and skill development in scientific writing, policy analysis, and emerging technologies such as AI. You will also have opportunities to collaborate with interdisciplinary teams, gaining exposure to the full breadth of FDA’s regulatory and scientific operations.

This fellowship will provide you with a strong foundation for a career in regulatory science, public health, or global health policy. By contributing to high-impact research projects spanning international regulatory operations, emerging technology, and pharmaceutical market policy, you will develop a robust portfolio of analytical, writing, and collaborative skills. Engagement with FDA’s global regulatory network and exposure to real-world policy challenges will position you as a competitive candidate for advanced roles in government, academia, or the private sector.

Mentor: The mentor for this opportunity is Harinder Chahal (ophsa@fda.hhs.gov). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date: July 13, 2026. Start date is flexible and will depend on a variety of factors.

Appointment Length: The appointment will initially be for one year, 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.

Citizenship Requirements: This opportunity is available to U.S. citizens and Lawful Permanent Residents (LPR) only.

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.

FDA Ethics Requirements

If an ORISE Fellow, to include their spouse and minor children, reports what is identified as a Significantly Regulated Organization (SRO) or prohibited investment fund financial interest in any amount, or a relationship with an SRO, except for spousal employment with an SRO, and the individual will not voluntarily divest the financial interest or terminate the relationship, then the individual is not placed at FDA. For additional requirements, see FDA Ethics for Nonemployee Scientists.

FDA requires ORISE participants to read and sign their FDA Education and Training Agreement within 30 days of his/her start date, setting forth the conditions and expectations for his/her educational appointment at the agency.  This agreement covers such topics as the following:

Non-employee nature of the ORISE appointment;
Prohibition on ORISE Fellows performing inherently governmental functions;
Obligation of ORISE Fellows to convey all necessary rights to the FDA regarding intellectual property conceived or first reduced to practice during their fellowship;
The fact that research materials and laboratory notebooks are the property of the FDA;
ORISE fellow’s obligation to protect and not to further disclose or use non-public information.
Qualifications
The qualified candidate should be currently pursuing or have received an associate’s, bachelor’s, or master’s degree in the one of the relevant fields.
Point of Contact
Ashley
Eligibility Requirements
Citizenship: LPR or U.S. Citizen
Degree: Associate’s Degree, Bachelor’s Degree, or Master’s Degree.