Karen Stoddart
Chief Regulatory Officer & Executive Director
Karen has extensive experience in the pharmaceutical industry gained in the development, manufacture and regulatory assurance of vaccines, biologics, active pharmaceutical ingredients and medicinal drug products.
She has worked in Europe and USA as well as UK and has led projects to prepare companies for their first global new drug registration and associated inspections from the regulatory authorities, including MHRA, EMA, FDA and ANVISA.
Prior to furthering her career in Regulatory and Quality, Karen worked in R & D and Operations. She has supported the conduct of safety and clinical efficacy studies around the world and has championed the introduction of new and improved quality systems to support Good Clinical, Manufacturing, Laboratory and Distribution Practices. As a member of the core team, she has been involved in new build, construction and remediation of pharmaceutical facilities for active ingredients, sterile and high risk medicinal products and has led the associated qualification and validation effort.
Karen’s experience has been gained in GSK, MSD, Chiroscience, Celltech, NextPharma Technologies, GW Pharmaceuticals, Sandoz and Vaccine Manufacturing and Innovation Centre. She is the Chair of Research Ethics at Cranfield University and is a Public Partner for National institute for Health and Care Research in conjunction with Imperial College, London.