Louise Lindved Karkov

Sr. Regulatory Affairs Specialist

Louise has more than 13 years of experience working with global regulatory affairs in the pharma industry. Her regulatory experience spans both the CMC, non-clinical and clinical development areas as well as development and maintenance projects.

Louise has been leading global regulatory affairs project teams world-wide and have had responsibility for both development and submission strategies. She has been involved in a broad range of EU applications, such as license applications, CTA, Orphan Drug Designations, PIP and PRIME applications. Furthermore, she has solid experience in working with Health Authorities worldwide, mainly EU, US, China and Japan. This includes preparation for and participation in authority meetings in EU, China as well as in US.