Monica Frazier, Ph.D., RAC

Associate Director, Regulatory Strategy

Monica Frazier, Ph.D., RAC

Associate Director, Regulatory Strategy

Dr. Monica Frazier has been contributing to and leading integrated product development programs and regulatory submissions at Rho for nearly a decade. Dr. Frazier has supported programs across the spectrum of development, including early stage pre-IND preparation, preparation and conduct of End of Phase 2 and pre-NDA/BLA meetings, and full service marketing application leadership. She has managed teams of scientists and experts in the development of complex documents, teamed with Rho’s biometrics experts to plan for integrated analyses, and has also authored protocols, clinical study reports, meeting packages, and nearly all clinical and nonclinical summaries for applications in a variety of indications. Her therapeutic areas experience is broad, and includes dermatology, neurology, pain, gastroenterology, ophthalmology, and rare genetic diseases.

After earning her Ph.D. in Biochemistry and Biophysics from the University of North Carolina at Chapel Hill in 2012, Dr. Frazier completed a 3-year postdoctoral research fellowship at the National Institute for Environmental Health Sciences before joining Rho.  Dr. Frazier joined Rho’s team of experts because she wanted to see a more direct impact of her scientific training. Since joining Rho, she has found a passion for the collaboration, team work, and focus on data that is required for the management of complex regulatory submissions for our sponsors.

This is what drives Monica:

“Supporting products that can help people is greatly motivating, and seeing products we’ve supported gain regulatory authority approval has been and continues to be very satisfying. I enjoy working with our sponsors together with our team of scientists, statisticians, programmers, and clinical operations experts to achieve their goals in the most efficient manner possible.”