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Responsibilities & Activities

As a regulatory affairs specialist in NIDDK, I am responsible for providing regulatory support for extramural programs and intramural investigators. For NIDDK extramural programs, I am tasked with ensuring that regulatory applications for Investigational New Drugs (IND) and Investigational Device Exemptions (IDE) are complete and accurate. For intramural programs, I provide regulatory support in terms of product development, including areas of contract preparation, product characterization, testing strategies, and implementation of nonclinical models.

Prior to joining NIDDK, I was a regulatory specialist in the Laboratory of Infectious Diseases in the National Institute of Allergy and Infectious Diseases where I worked with multiple investigators to translate their drug products from the laboratory bench to clinical studies. This included vaccine candidates against a variety of infectious diseases like influenza, respiratory syncytial virus, Epstein-Barr virus, and COVID19. Prior to my tenure at the National Institutes of Health, I was a regulator in the Office of Tissues and Advanced Therapies at the US Food and Drug Administration. In this role, I was tasked with reviewing different regulatory applications for novel biological drugs and devices at all stages of development from drug/device discovery to licensure. Additionally, I was engaged in regulatory research using high-throughput technologies to evaluate cell-based therapies to improve the agency’s understanding of these complex drug products.

Committees & Working Groups

• Clinical Studies Working Group, Member