US Food and Drug Administration
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FDA Bioequivalence of Complex Generic Products Fellowship U.S. Food and Drug Administration (FDA) in United States
Degree Level
Postdoc
Field of study
Pharmacology
Funding
Monthly stipend commensurate with educational level and experience; appointment initially for one year and may be renewed contingent on FDA recommendation and availability of funds.
Deadline
Mar 30, 2027
Country
United States
University
US Food and Drug Administration
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About this position
This FDA fellowship focuses on bioequivalence for complex generic drug products, with research centered on difficult-to-characterize formulations and dosage forms. The project spans parenteral, intrauterine, intravaginal, ophthalmic, otic, inhalation, nasal, topical, transdermal, and transmucosal products, and aims to understand formulations approved under abbreviated new drug applications and NDAs.
Working in the Office of Generic Drugs / Office of Research and Standards within the Center for Drug Evaluation and Research, the participant will help identify and develop in vitro, in vivo, and in silico techniques to evaluate how complexity factors influence test-product performance relative to the reference listed drug. The fellowship also addresses scientific gaps in applying novel technologies to characterize complex generic products and support product development.
Under the guidance of mentor Yan Wang, the participant will gain experience with the scientific and regulatory challenges involved in establishing bioequivalence for complex topical, transdermal, and transmucosal products, including combination drug-device products. The opportunity emphasizes collaboration across disciplines and the development of new study designs for regulatory science applications at the FDA in Silver Spring, Maryland.
Funding details
Monthly stipend commensurate with educational level and experience; appointment initially for one year and may be renewed contingent on FDA recommendation and availability of funds.
What's required
The qualified candidate should be currently pursuing or have received a doctoral degree in pharmaceutical science, pharmacology, pharmacy, or a related area. Applicants must be U.S. citizens, Lawful Permanent Residents (LPR), or eligible foreign nationals under the program's immigration guidelines. Proof of health insurance is required, and the applicant must be able to pass a successful background investigation by the Office of Personnel Management; OPM can complete the investigation only for individuals, including non-US citizens, who have resided in the United States for a total of three of the past five years.
How to apply
Submit an application through the Zintellect/ORISE portal using the reference code FDA-CDER-2026-0012. Upload transcripts, a current resume/CV, and one educational or professional recommendation, all in English or with official English translations. If you have questions, email [email protected] and include the reference code.
Make your next move.
Prepare your application
Review drafts and confirm requirements with the university.
Make your next move.
Prepare your application
Review drafts and confirm requirements with the university.