Keith Watson, a PhD Biochemist who is also an ex-regulator with 30 years of experience in academia, manufacturing, development, regulation, consultancy and regulatory policy environments.  This has been gained from working at a tier one CMDO, as a quality assessor at the MHRA, being EU Practice lead for CMC at a global CRO and senior regulatory, policy and strategy positions in small to medium sized pharma and/or biotech Companies.

Whilst at the MHRA, Keith was an active participant in UK’s Biologics and Vaccines Expert Advisory Group (BVEAG) and Committee for Human Medicines (CHM) as well their European counterparts, Biologics Working Party (BWP), and Committee for Human Medicinal Products (CHMP).

Keith has reviewed and compiled multiple marketing authorizations and also participated or led over 100 scientific advices with National and Regional regulatory bodies (UK, EMA, FDA, TGA, ANVISA amongst others). He has a thorough understanding of the scientific advice and marketing authorization procedures and used to developing questions, positions and scientific arguments to convince the regulator to support innovative solutions.