Nancy Pire-Smerkanich, DRSc, MS, is an assistant professor in the Department of Regulatory and Quality Sciences at USC Mann. She received her faculty appointment after successfully completing her doctoral dissertation on “Benefits Risk Frameworks – Implementation in Industry” in 2015.
In addition to teaching in courses related to drug development and clinical trials, she continues to provide regulatory guidance to industry peers. She brings to academia many years of practical regulatory knowledge and experience from industry, where she participated in all regulatory aspects of product development, having served as regulatory liaison, U.S. agent and global regulatory lead across all therapeutic areas.
Known for her dedication to education and mentoring across industry, Pire-Smerkanich continues to be recognized for her ability to provide accurate, relevant and dynamic instruction on both the technical and strategic aspects of global regulatory affairs and for her service to professional organizations such as the Drug Information Association and The Organization for Professionals in Regulatory Affairs.