Marie Gårdmark CEO and Senior consultant
M Sci Pharm, Ph D
marie.gardmark@regsmart.se
+46 (0)765 – 27 62 65
Marie has a wide range of experience from drug development. She has more than 10 years’ experience as a regulator at the Medical Product Agency in Sweden (MPA), a major contributor to EU regulatory decision making. As Director of Licensing at MPA she was responsible for activities and decisions related to drug approvals and life cycle management including clinical trials and scientific advice. She led the agency’s work with innovation support. Her responsibility covered products of both biological and chemical origin within human and veterinary medicine. As a regulator she has actively contributed to development of new guidelines and legislation.
Dr Gårdmark has 10 years of experience from senior roles in small and big pharma companies mainly in Regulatory R&D as exemplified by development and implementation of global regulatory strategies, due diligence activities and scientific advice meetings in EU and US. Her main focus has been in clinical and preclinical research.
Her scientific background is in clinical pharmacology and pharmacometrics and she has several years of experience from early drug development. She holds a PhD in pharmacokinetics from Uppsala University, Sweden.
Marie Gårdmark is co-founder of RegSmart Life Science AB.