Nick Lee

My first “real” job was developing and implementing NIR applications in primary and secondary manufacturing, which I thoroughly enjoyed. Since then, I have been involved in a number of different organisations in different pharma-industry sectors (originator - generics - CRO; medical device - combination products - medicinals), in increasingly senior roles, culminating in Director of R&D for a small biotechnology company based in the midlands of Ireland. Due to some unintended consequences of global fiscal policy some years ago, I found myself a new challenge in the HPRA, the Competent Authority of Ireland. In my role at the HPRA, I have responsibility for assessment of many procedure types including CAPs, CTAs and EMA/national Scientific Advice. As well as being the EC Regulatory Topic Lead for ICH Q13 and HPRA lead for Continuous Manufacturing, I am also the departmental lead for Device-Drug combination products. I am also the Irish delegate to the QWP - a working party of the CHMP - and a member of the EMA PAT team.