Lars Olsen

Executive Regulatory Specialist

Lars has more than 35 years of experience in international regulatory affairs spanning from the Danish Medicines Agency through pharma and biotech to consulting.

Lars has a very strategic mindset and has over the years been regulatory EU and US responsible for several drug development projects. As such he has prepared regulatory strategies for both regions and lead preparations and conduct of several FDA, EMA and national European authority meetings. Lars’ regulatory experience covers both the CMC, preclinical and clinical parts of the regulatory dossier as well as administrative aspects of submissions, which allows him to maintain a holistic regulatory strategic perspective when engaged in preparing and reviewing regulatory documentation. During Due Dilligence processes Lars it able to contribute from both licensor and licencee’s perspective.