Duke Leadership Academy Scholars Profile

Amanda Parrish

Amanda Parrish

Title: Director of Regulatory Affairs and Quality
Location: Office of Regulatory Affairs and Quality
Senior Management Area: School of Medicine
Class Year: 2019

Amanda Parrish, PhD, RAC is the Director of Regulatory
Affairs and Quality in the Office of Regulatory Affairs
and Quality (ORAQ) within the Duke University School of
Medicine. In this role, Dr. Parrish oversees a team of
Regulatory and Quality professionals who provide guidance
on FDA regulations for product development, clinical
trials research, and manufacturing at Duke.

Dr. Parrish is responsible for providing support and
guidance to investigators regarding the regulatory and
quality requirements relevant to their clinical research
activities. She performs a variety of services including
regulatory/quality education, regulatory/quality
consultation, and support for regulatory submissions. She
supports Duke investigators and associated project teams
with regulatory needs in a variety of therapeutic areas,
including drug, biologic, and device regulatory
submissions. She has conducted numerous meetings with the
FDA, and her regulatory/GMP experience ranges from early
Phase 1 activities through product licensing. She was the
primary regulatory project leader for the US approval of
the Carolinas Cord Blood Bank BLA and continues to support
the regulatory and quality assurance activities associated
with the Duke BLA. In addition, Dr. Parrish also oversees
and manages implementation of new educational,
operational, and collaborative initiatives within ORAQ.

After receiving her undergraduate degree in biology from
Emory University, Dr. Parrish worked for two years in a
laboratory performing prostate cancer research. She came
to Duke University in 2004 to conduct her graduate
research studies, where she obtained a PhD in Molecular
Cancer Biology with a certificate in Cell and Molecular
Biology. Her graduate research focused on regulation of
the apoptotic cell death process. Following a short post-
doc in her graduate lab and an internship with the Duke
Translational Medicine Institute (DTMI) Regulatory Affairs
office, in 2010, she moved into a role as a Regulatory
Affairs Scientist at Duke University. Dr. Parrish holds
the US Regulatory Affairs Certification (RAC) from the
Regulatory Affairs Professional Society.