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FDA Public Health and Regulatory Research Fellowship

Job in Silver Spring, Montgomery County, Maryland, 20900, USA
Listing for: Oak Ridge Institute for Science and Education
Full Time position
Listed on 2026-10-05
Job specializations:
  • Healthcare
    Public Health
  • Research/Development
    Public Health
Salary/Wage Range or Industry Benchmark: 7600 USD Monthly USD 7600.00 MONTH
Job Description & How to Apply Below

Organization: U.S. Food and Drug Administration (FDA)

Reference Code: FDA-OC-

Final date to receive applications: 11/27/2026 3:00:00 PM Eastern Time Zone

FDA Office and

Location:

Office of Commissioner (OC), Public Health Strategy and Analysis Staff (PHSA), located in Silver Spring, Maryland.

Description: Applications will be reviewed on a rolling basis.

Research Project

Project 1:
Drug Competition and Access

You will participate in research and analysis examining FDA's drug approval programs, generic and biosimilar market dynamics, and the impact of regulatory pathways on drug availability and affordability for American consumers. Activities will include analyzing relevant data and regulatory frameworks, investigating market competition trends, and engaging with policy-relevant publications that can inform FDA priorities aimed at improving access to safe, effective, and affordable medicines.

Learning

Objectives – Project 1
  • 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

You will investigate the design, utilization, and public health outcomes associated with FDA's regulatory pathways, including expedited programs and novel approval mechanisms. Activities will include analyzing data on pathway utilization, researching associated public health outcomes, and participating in findings that can inform policy development and Agency priorities.

Learning Objectives – Project 2
  • 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

You will participate in research involving FDA's international public health mission. Activities will include analyzing global drug quality issues, investigating cross-border regulatory challenges, and researching partnerships aimed at strengthening international regulatory systems. You will also engage with mentors to research, draft, and contribute to scientific papers and policy-relevant publications on global health topics.

Learning Objectives – Project 3
  • 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: ophsa.gov

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…

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