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Kristen Foss, PhD, RAC is an Associate Director of Regulatory Affairs in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Foss works with a team of Regulatory Affairs professionals who are responsible for providing support and guidance to investigators and project teams regarding the regulatory requirements relevant to their research study activities. Dr. Foss assists project teams developing or studying investigational drugs, biologics, and devices, and she performs a variety of services including regulatory education, regulatory consultation, and support for regulatory submissions. She has conducted several meetings with the FDA and has assisted with successful regulatory applications for both a Breakthrough Device Designation Request and a Breakthrough Therapy Designation Request. Dr. Foss also oversees and manages implementation of operational initiatives and eCTD publishing activities within ORAQ.
Dr. Foss received her undergraduate degree in biology from South Dakota State University and then worked as a research associate at the Translational Genomics Research Institute in Phoenix, Arizona. Dr. Foss conducted her graduate research at Duke University, where she earned her PhD in Pharmacology with a certificate in Cell and Molecular Biology. During her graduate training, Dr. Foss was the recipient of a Ruth L. Kirschstein-NRSA Predoctoral Fellowship and a Robert J. Fitzgerald Scholar Award. She was also selected to participate in the Duke Scholars in Molecular Medicine Program in Oncology and Regenerative Medicine. Dr. Foss holds the US Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society.