Billie Wiltison

Billie Wiltison has over 20 years of experience in regulatory affairs and pharmaceutical industry. Billie is currently serving as the Vice President of Regulatory Affairs at PAI Pharma since July 2022. Prior to that, they worked as a Senior Director of Regulatory Affairs at PAI Pharma (formerly Vertice Pharma) from September 2019 to June 2022. Additionally, they worked as an Independent Consultant from January 2019 to August 2019.

Before joining PAI Pharma, they held various roles at Impax Laboratories, starting as a Senior Director of CMC Regulatory Affairs from February 2015 to December 2018. Prior to that, they worked as a Senior Consultant at PAREXEL from April 2013 to January 2015, where they provided scientific advice and direction to pharmaceutical companies and expertise on regulatory requirements for small molecule drugs.

Earlier in their career, they gained experience at Mylan in multiple positions, including Associate Director Special Projects - Regulatory Affairs, Senior Alliance Manager - Regulatory Affairs, Regulatory Affairs Manager, Senior Regulatory Affairs Associate, Regulatory Affairs Associate, and Chemist, spanning from July 2000 to March 2013. In these roles, they collected and reported regulatory planning, conducted research on global regulatory issues, managed regulatory projects, and oversaw operational aspects.

Overall, Billie Wiltison has demonstrated expertise in regulatory affairs, specifically in Chemistry, Manufacturing, Controls (CMC) requirements, providing advice and guidance to support the development and approval of pharmaceutical products.

Billie Wiltison earned an M.S. degree in Regulatory Science from the University of Southern California between 2005 and 2010.