Michelle Leu

Michelle Leu is a Regulatory Affairs Professional at Ambu A/S since February 2021, specializing in regulatory strategies for class IIa legacy devices in the EU and class II developmental products in the US. Prior experience includes roles at LEO Pharma, where responsibilities encompassed Regulatory CMC Specialist and Regulatory Submission Manager, focusing on CMC documentation and coordinating various regulatory submissions. Michelle has a background in information retrieval and market research through earlier positions as an Information Associate with CAP Partner and multiple student assistant roles at LEO Pharma. Academic qualifications include an MSc in Pharmacy from the University of Copenhagen, an exchange program at the National University of Singapore, and a BSc in Pharmacy from the same university, complemented by a high school education in Chemistry and Biology.