Director Regulatory Affairs – S-cubed Ltd
I’ve been working in Regulatory Affairs for over 25 years now in small and large pharma as well as CROs: the last seven years at S-cubed. I can’t imagine working anywhere else – the people here are ace! I joined the company having known Mark (Lipscombe) and Stephen (Thompson) since our time at Origin together and I was ready for a move. The work here is extremely varied and I never stop learning, especially with a team that has such a wide knowledge base.
Making a difference
The best part of being at S-cubed, other than working with fantastic people, is that there is great satisfaction from making a real difference to our clients. There’s nothing better than that moment when you have helped a stressed client with a problem that they’ve been struggling with. Even the short-term wins when working on a larger project, are rewarding and clients really appreciate it. We do tend to go above and beyond the scope of work in our efforts to resolve some of the thornier challenges that clients face. I’ve been the client: I know what it’s like and what I would want from a consultancy service provider. I would want to feel that the issue is as important to them as it is to me. So, part of this is about integrity and doing the right thing. We often have clients come to us as they simply didn’t receive the support they wanted elsewhere. We listen carefully, and offer a flexible, tailored service. Consequently, job satisfaction is high because we serve our clients well.
From Canada to Yorkshire to Regulatory Affairs
My early life was spent in Canada. We moved back to the UK when I was 15, after my Dad passed away. Life changed rapidly. We arrived back on the Sunday and I was in school on Monday. I didn’t understand a word people were saying, I hadn’t heard a Yorkshire accent before and there I was, straight into O-Level year! Of course, no-one knew whether I was capable of passing anything, so they double entered me for O-Levels and CSEs. I must be one of the few people with a whole set of CSE Grade 1s alongside my O-Levels.
I always knew I wanted to work in the pharmaceutical industry. I went to college for 6th Form and studied Chemistry, Biology and Physics, then completed my degree in Combined Sciences before gaining a Masters in Biochemical Engineering. My first ‘proper’ job was at Wellcome where I joined their graduate training scheme. It was a great opportunity to learn about all aspects of the pharmaceutical business and I quickly realised I wanted to go into Regulatory Affairs. A few years later, I secured a position at a small generics company, Lagap Pharmaceuticals (now Sandoz) where I was fortunate to quickly gain exposure to all aspects of Regulatory Affairs, working closely with other company functions and third parties.
If there’s some advice I would give to people coming into the field of Regulatory Affairs, it would be to question what you read or are told. Don’t necessarily accept the first answer. You have to have tenacity and resilience. Don’t give up when you can’t sort something out straight away.
Away from work
Now that my own family is older it’s great to have some more time for me. I decided to improve my level of fitness starting with getting back into running. I’ve taken a long run up at it … about 3 years but think I can now say I ‘enjoy’ the Parkrun 5k. I also go to several exercise classes with my daughter. Our shared favourite is Clubbercise®; club music, glow sticks, disco lights and recently, singing along to the cheesy numbers! It’s kind of dark, so it doesn’t matter how ridiculous you look.
Five words to describe me: positive, fun, caring, friendly, and competitive. Don’t talk to my family about competitive, we try to outdo each other at every opportunity, dishwasher stacking at speed, even who gets the best eye test results!
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...