Regulatory consultant life science
For 19 years I have worked with Regulatory Affairs at Novo, Roche, Leo-Pharma, Danish biotech and Dako (diagnostics). I have a broad knowledge on Regulatory affairs development, maintenance of the business licenses and also management in a Global organisation. My strenght is Regulatory strategies and Development of Innovative medicines, Personalised Medicine and Diagnostics. I have extensive experience working with the European Medicines Agency with orphan drugs, scientific advice and also the "preauthorisation unit" in getting Innovative Medicines approved since 1995. I have taken products through early development to Marketing Authorisation in Europe and the US. Have prepared and held many important meetings negotiating with the FDA and other important health authorities on drugs as well as diagnostics. I have and have had Global leadership with employees in China, Japan, US, Denmark, Middle East and GCC and have an understanding of what it takes to get world wide market access and building an efficient organisation, partner and CRO management. I have also supported companies in making Business and Development Plans and meetings regarding funding. I am a member of Danish Biotech and am mentor for start-ups from the university in Copenhagen.