Shaily Arora, PharmD

Dr. Shaily Arora is the Executive Regulatory Science Director in Oncology Regulatory Science, Strategy and Excellence group, at AstraZeneca. She has nearly a decade of drug development experience and is an accomplished leader excelling in achieving innovative solutions through cross-functional, regional, and global collaboration among diverse teams of multi-skilled individuals. In her current role, Dr. Arora leads a group of Regulatory Affairs Directors (RAD), Senior RAD, and Global Regulatory Leads (GRL) on formulating innovative global regulatory strategies for early and late stage oncology products. Dr. Arora has an immaculate record of strong regulatory and scientific leadership demonstrated by mentoring high performance teams, developing regulatory strategies across hematology-oncology therapeutic areas, and standardizing processes with the goal of successful advancement of drugs towards expeditious approval. Prior to her role at AstraZeneca, Dr. Arora served as the Associate Director for Safety in the Office of Oncologic Diseases, at the Food and Drug Administration, where she served as Signatory Authority and oversaw consistent evaluation of safety across the five oncology review divisions from the pre-market phase through post-market evaluation.

Dr. Arora earned her Doctor of Pharmacy degree from University of California, San Francisco and completed a residency training, specializing in hematology-oncology at the University of Kentucky. Aside from her clinical training, Dr. Arora has additional substantive basic science research experience including cell and molecular biology and immunology that she gained at academic and major industry institutions.