Director of Regulatory Affairs – S-cubed Ltd
I have now worked at S-cubed for over 10 years and it has flown by. I worked with Stephen Thompson, Tony Mitchell and Irene Dawe at SRA Constella, then Stephen left to join Mark Lipscombe at S-cubed. In March 2009, Mark and Stephen got in touch and persuaded me to join them. I had been really happy working at Constella but when it was taken over by SRA, as with all small companies being swallowed up by a larger corporation, things changed and so I didn’t need too much convincing to leave. It was such an exciting time to be part of S-cubed, right from the very beginning. There were so many challenges and it was a fantastic experience.
From Bench to Regulatory Affairs
I didn’t start out working in Regulatory Affairs. I studied Chemistry back in France and finished my PhD in 2002. When I started looking for a job, there was very little available in research. I looked all over Europe. In the end, I had an offer in Germany and one in the UK. I took the job in the UK working as a medicinal chemist at Evotec. I only planned to stay in the UK for 2 – 3 years and then I’d return to France but here I am! After 6 years at the bench, I was ready for a new challenge but there were very limited progression opportunities at the time. It was while I was on maternity leave that I thought about my options. A friend had said that working at Constella was great and that they had a 6-month programme to train people in regulatory affairs. I thought it was the perfect opportunity for a career change and, with my husband’s support, went for it.
My work now is so varied. I can be working with small companies starting out with their development to major pharmaceutical companies on licencing and maintenance of products. I never know what project I will be working on next and there is an element of constantly learning something new. I can imagine I will be happily working here for a long time to come. The biggest change in the last 5 years has been the scope of my work. I am a Director now, so my role evolved, and I am more involved in the business sides of things, which I really enjoy. The company also has a great approach when it comes to work life balance. I tend to plan my work around my home life, so I can collect my sons from school or go and see something they are doing, or work from home if I need to. Having this flexibility is fantastic!
When I am not taking the boys around to their different activities, I do get some time to myself. I run to let off steam and keep fit, and I really enjoy it. I just put on a pair of trainers and go which I can fit into my crazy schedule. My husband has run 8 or 9 marathons and is now running ultramarathons of 50 miles. I am not doing that! I think the furthest I have run is about 18 kilometres which is quite far enough! I also do Pilates once a week: it is a nice way to improve core strength, flexibility, and relax. I’m also involved in the Abingdon Athletics Club (taking care of the admin side of the young athletes coaching). I love listening to music, going to concerts, and reading (which I try to do every day). I’m never bored!
Five words to describe me? Quiet (perhaps a little too quiet but that is me), a good listener, caring, proactive, organised (although that can be good and bad – according to my husband, it’s bad!).
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...