Nicholas

Director of Global Regulatory Affairs

“As Director of Global Regulatory Affairs, I manage a team of approximately 35 people responsible for preparing labelling documents for vaccines and writing clinical and non-clinical dossiers. My day-to-day role involves meeting with team members, reviewing documents and providing expert input to support other teams. I relish using my experience and expertise to help Regulatory Affairs and the wider business find better ways of working and advance their projects .

I’ve had lots of opportunities during my time with GSK, but probably the best was the chance to work on the US regulatory submission for Cervarix, our human papilloma virus (HPV) vaccine. By being the GSK point of contact with the FDA for this submission, I really learnt on how you work as someone based in the country compared to the central organization as well as deepening my understanding on US regulatory affairs. I’ve been lucky to have taken on roles of increasing responsibility and complexity, starting as a Scientific Writer for the malaria vaccine project and culminating as a Head of Labelling, Clinical & Non-clinical Regulatory Affairs in GSK Vaccines.

I’m motivated by the real need for the vaccines we create. After talking to colleagues and external investigators,  I discovered that, when they were planning the clinical trials for our malaria vaccine, there was no shortage of volunteers to test it. There’s so much medical need. That’s when you realise what you’re doing is important – and that’s why I’m still passionate about my work after spending 16 years at GSK.”