Patrizia Nestby, PhD, MSc (Regulatory Affairs), FTOPRA, is Director and Founder of Pioneer Regulatory Limited. Patrizia is a biomedical scientist by training; she completed her studies at the University of Leiden and a PhD in neuropharmacology at the Faculty of Medicine of the Free University in Amsterdam in The Netherlands.
Patrizia is fluent in Dutch (native) and English. She is Italian, was raised in The Netherlands and currently lives in England, United Kingdom.
After her academic studies, Patrizia embarked on a career in pharmaceutical development. She completed an MSc in Regulatory Affairs with distinction, and has 20 years of experience in global strategic and operational regulatory affairs working in both industry and consulting environments. Patrizia has held positions that afforded leadership experience in defining and executing global regulatory strategy for medicinal products in early and late stage development.
Patrizia has extensive experience with regulatory project leadership and management of multi-regional and disciplinary teams on large complex projects, including marketing authorisation applications/new drug applications. Experience includes agency interactions, managing scientific advice procedures, authoring and review of submission documents.
Patrizia is an Honorary Member of TOPRA, The Organisation for Professionals in Regulatory Affairs.