Bob Clay established his regulatory consultancy practice through Highbury Regulatory Science in 2014 which supports small/medium size companies and their investors to develop regulatory/business strategies across multiple therapeutic and geographic areas. Before this, he was a VP of Global Regulatory Affairs at AstraZeneca with responsibility for oncology, infection, and personalised healthcare.
He is a member of the Expert Scientific Advisory Committee for Medicines for Malaria Venture (MMV) and works with several, not for profit organisations involved in global health initiatives. He was a board member of TOPRA (The Organisation of Professional Regulatory Affairs) from 2014 – 2018, and President for 2017.
Bob is a pharmacist with more than 30 years’ experience in drug development, leading the global regulatory approval of many products across a range of therapy areas including metabolic diseases, neuroscience, cancer, and infection, involving more than 15 new substances. Earlier in his career, he was a formulation scientist and pharmaceutical reviewer at UK regulatory agency. Bob has held significant leadership roles in regulatory affairs in regional and global functions at several companies including AstraZeneca and Pfizer and served as Chief Regulatory Officer at Kinapse (2014-2017).