Julie De Smet is Director CMC Regulatory at Ardena, based in Ghent, Belgium. She brings extensive expertise in CMC writing, dossier development, and regulatory strategy, supporting pharmaceutical development programmes from early phase through commercial.
Julie joined Ardena, then known as Pharmavize, in 2012 as Regulatory Affairs Officer and advanced through several leadership positions, including Regulatory Affairs Project Manager, Subject Matter Expert in CMC writing, and Associate Director of Dossier Development. Since 2021, she has co-led the CMC Regulatory Business Unit together with Anke Moret, with a strong focus on scientific content, dossier quality, and regulatory strategy.
Julie obtained her Master’s degree in Pharmaceutical Sciences from Ghent University in 2006 and completed her PhD in 2012, specialising in analytical method development to support pharmacokinetic studies. In her current role, she collaborates closely with Anke to ensure high-quality regulatory deliverables and to strengthen the integration of scientific expertise and regulatory requirements across projects.
