Director of Regulatory Affairs and Quality Assurance
From University to Regulatory Affairs
After leaving University, I started my career in the pharmaceutical industry working at a contract manufacturer in Swindon, where I was performing quality control testing in the finished product laboratory. After a few years at this, I felt I needed to try something outside of a lab environment, so I explored what my options were, this was when I first learnt about Regulatory Affairs. Although I had no previous experience, a small generic company based in Surrey gave me my first Regulatory role. It was a small team and we often had to get involved with a bit of everything, which was great experience for me at that time. This was where I first met Nicola Wright. I later moved on to Sandoz, the generic arm of Novartis, where I spent a number of years. Eventually I wanted to gain some experience in branded pharma, so I moved to Merck Serono where I was responsible for Regulatory Affairs and Quality Assurance for UK and Ireland.
Moving to S-cubed
I saw Nicola again a number of years later and she asked me if I had ever considered consulting. It wasn’t really something I had thought about before, and agreed to a chat with Nicola, Stephen Thompson and Mark Lipscombe to find out a bit more about S-cubed. I liked what they told me about the company, its culture and what S-cubed was about.
Working at S-cubed
There is so much I enjoy about my job. It’s great going into the office, there is an excellent collaboration between the team, and although we all manage individual clients and projects, you never feel like you’re working on your own; if there are questions or issues, someone always has the answer, or has come across a similar problem before. Equally, the variety of work means that life is never mundane and there are always new challenges. I like to think of us as an extension to our clients’ in-house teams, and feel that we try to provide more than just an external service. We have worked with some of our clients for several years (even before S-cubed in some cases) and, as a result, we are invested in the people and their success, especially where we have been there from early development stages through to a commercial product launch.
Our latest regulatory update focuses on the responsibilities of the Marketing Authorisation Holder.
Bohua Li introduces an S-cubed extension for adding user comments in a Qlik Sense application, along with a guide for users to implement the extension themselves.
This article provides an overview of PRIME, Breakthrough Therapy and Fast Track regulatory procedures intended to optimise the development of medicines that target an unmet medical need.
Regulatory Affairs Expert Tony Mitchell co-authors a case study for a new IBS Drug This is case study for a joint project S-cubed worked on for a new drug for IBS – PharmaVentures was the lead company and they were providing market valuation expertise, Apex Healthcare...