Bob graduated in Pharmacy from the University of Bath in 1980 and subsequently completed an MSc in BioPharmacy, from the University of London, and an MBA, from the Open University.
Following completion of his professional training in hospital pharmacy, he joined the pharmaceutical industry as a formulation scientist at the UK laboratories of Rhone-Poulenc. Later, he joined the UK Licensing Authority as a pharmaceutical assessor and has held regulatory affairs leadership roles with several pharmaceutical companies including Wellcome, Zambon, Pfizer and AstraZeneca. Bob was Chief Regulatory Officer at Kinapse, a leading CRO in outsourcing to the biopharma industry.
Bob has experience across the development continuum from research through commercialisation, leading regulatory projects throughout the product lifecycle. He has led projects in a wide range of therapeutic areas through EU centralised and mutual recognition procedures and global development programmes. He has a strong interest in the impact of regulation on the development of innovative medicines and healthcare policy matters.
Bob is a member of the Expert Scientific Advisory Committee for Medicines for Malaria Venture (MMV) and a participant in several working groups at CPTR (Critical Path for TB Regimens) and other Critical Path Institute programmes. Bob joined the board of TOPRA in January 2014 and was President for 2017, completing his final term at the end of 2018.
Bob is a Board member at the Academy of Pharmaceutical Sciences.
Academy of Pharmaceutical Sciences
Bob is a member of the board and has been a member of APSGB for many years having begun his career as a formulation scientist and regulatory reviewer.
MMV is a not for profit public-private venture established as a foundation in 1999. Bob was a member of the Expert Scientific Advisory Committee from 2012-18 and continues to support teams as an adviser.
The Organisation for Professionals in Regulatory Affairs (TOPRA)
Bob Clay is a Fellow of TOPRA and was a member of the board (2014-8, President 2017) and regular speaker on MSc and other educational seminars.
Meetings include TOPRA India 2017: Building Regulatory Excellence. Bob Clay presented at this meeting in Bangalore - 16-17 May 2017 and workshops hosted by Pharmaceutical Society of Singapore and Hong Kong Association of the Pharmaceutical Industry HKAPI.
Critical Path to TB Regimens
CPTR Initiative aims to speed the development of new treatment regimens for tuberculosis. Bob has participated in this initiative since its launch in March 2010 and has contributed to several workgroups and presented at annual meetings.
Presentation from October 2013 Meeting and video.
Bob has supported various regulatory interactions with FDA and EMA, including the qualification of the hollow-fiber model in TB drug development.
Bob is a member of several professional associations:
Regulatory Affairs Professionals Society (RAPS);
Drug Information Association (DIA);
European Society of Clinical Microbiology and Infectious Diseases (ESCMID);
International Union Against Tuberculosis and Lung Disease (The Union);
Institute of Directors (IoD); and
Royal Pharmaceutical Society of Great Britain (RPS)
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