Sophie Bertilsson
Senior Advisor
M Sci, PhD, Organic Chemistry
sophie.bertilsson@regsmart.se +46 (0)733 – 91 66 30
Sophie has broad experience of drug development from both industry and regulatory authority positions. Most recently, she worked at the Swedish Medical Products Agency (MPA) responsible for evaluating the quality of drug products in clinical trial and market authorization applications as well as providing scientific advice to drug developers.
More about Sophie
Sophie has a solid scientific and regulatory background in pharmaceutical development with experience of a wide variety of chemical entities and drug formulations.
Prior to joining Swedish MPA, Sophie worked 15+ years at AstraZeneca R&D with drug projects at different stage of development as regulatory CMC expert, project manager and senior scientist. As regulatory CMC expert, she was responsible for development and implementation of global regulatory CMC strategies, regulatory documentation, interactions with health authorities as well as activities related to in- and out- licensing.
Sophie has a special interest in drug substance process development as well as the development of robust and scientifically sound control strategies. She holds a PhD in Organic Chemistry from Uppsala University, Sweden.