Amanda B. Parrish, PhD, RAC (US) is Associate Dean and Executive Director of the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. In this role, Dr. Parrish provides collaboration, strategic leadership, and institutional oversight of FDA Regulatory Affairs and Good Manufacturing Practice (GMP) Quality systems and infrastructure supporting Duke’s research, education, and clinical missions. She leads a multidisciplinary team of regulatory affairs and quality professionals responsible for all Duke‑sponsored FDA regulatory applications, including hundreds of annual submissions spanning a diversity of investigational and commercial product types, including drugs, biologics, cellular therapies, medical devices, and a licensed biologic.

Under Dr. Parrish’s leadership, ORAQ’s quality programs provide oversight for multiple campus manufacturing facilities conducting Phase 1 through commercial manufacturing as well as Good Tissue Practice (GTP)-regulated activities. She and her team bring manufacturing and GMP Quality experience spanning biologics, cellular and gene therapies, peptide and mRNA products, and small molecules. Dr. Parrish serves as Duke’s senior authorized representative for FDA interactions related to GMP manufacturing. She has led numerous FDA interactions across all stages of product development and was the regulatory lead for the U.S. approval of the Duke/Carolinas Cord Blood Bank Biologics License Application (BLA) in 2012. She and her team are committed to applying FDA expectations within the academic setting to facilitate efficient translation of scientific discoveries into research and patient care while maintaining rigorous standards for safety, quality, and ethics. Dr. Parrish and the entire office continue to strengthen Duke’s leadership in FDA regulatory affairs and GMP quality by advancing compliance, streamlining regulatory and manufacturing processes, and fostering partnerships that position Duke as a national model for excellence that can be disseminated and shared across academic medical centers, with a vision to create strong product development support for innovation and science at Duke.

Beyond Duke, with others on her team, Dr. Parrish was a founding member of ReGARDD (Regulatory Guidance for Academic Research of Drugs and Devices), a CTSA‑funded regional collaboration that provides training resources, templates, and regulatory guidance to academic investigators. She served as co-principal investigator for Duke’s sub‑award on the U01 Collaborative Innovation Award (TEAMSS), working with multiple academic centers to transform expanded access policy and practice through multisite integration, dissemination of best practices, and real‑world data generation. Dr. Parrish leads FDA-regulatory and manufacturing content for the Duke BME/Health Policy course, Regulation and Reimbursement of Medical Products: Practice and Policy, and serves as co‑chair of the regulatory advisory subcommittee for the Duke Health Algorithm‑Based Clinical Decision Support (ABCDS) Committee.

Dr. Parrish earned her Bachelor of Science degree in Biology from Emory University and her PhD in Molecular Cancer Biology from Duke University, where her graduate research focused on regulation of apoptotic cell death. She holds U.S. Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society.