Nancy Pire-Smerkanich, DRSc, MS
Regulatory Associate Director, Regulatory Knowledge and Support
SC CTSI Role
Dr. Pire-Smerkanich supports the Regulatory Knowledge and Support (RKS) within Clinical Research Support (CRS) of SC-CTSI, which is dedicated to improving the quality of clinical trials conducted in academia through innovative approaches to education and training. Dr. Smerkanich also provides regulatory consulting to USC investigators who are looking for help in developing regulatory strategies, which will enable the translation of medical products from discovery through proof of concept, and eventually to the market.
Dr. Smerkanich is an Assistant Professor, Department of Regulatory and Quality Sciences in the School of Pharmacy at the University of Southern California (USC). Dr. Smerkanich 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 support and guidance to her industry peers. Nancy brings many years of practical regulatory knowledge and experience to her role in academia. As the former (Executive) Vice President of Global Regulatory Affairs at Octagon Research Solutions, and a senior Consultant in Regulatory Affairs at Accenture, Nancy was responsible for advising sponsors on regulatory strategy and submission development. With over 30 years of experience, Dr. Smerkanich has participated in all regulatory aspects of product development, having served as Regulatory Liaison, US Agent, and Global Regulatory Lead across all therapeutic areas. Known for her dedication to education and mentoring across industry, Nancy is recognized for her ability to provide accurate, relevant and dynamic instruction on both the technical and strategic aspects of global regulatory affairs. Dr. Pire-Smerkanich contributes to support professional organizations such as the Drug Information Association (DIA) and The Organization for Professionals in Regulatory Affairs (TOPRA). She has twice been awarded Outstanding Volunteer Service awards from DIA in 2004 and 2017 and is a Visiting Fellow in the Department of Pharmacy Practice and Postgraduate Medicine at the University of Hertfordshire in the UK.
Travel and exploring California with her husband Mark.