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Paul Smith
Featured Profile: 
At A Glance
Licensed Body: 
Scientist Type: 
South East
First Degree: 
Molecular Biology
Regulatory Affairs Consultant
Works For: 
Professional Regulatory Services Ltd
Pet Hates: 
Unanticipated problems
Burning Ambition: 
To help global product development for a breakthrough, first-in-class medicine
I would like to read people’s minds and possibly influence their thoughts just so I can get my own way more often
Big Picture
When you were a child, what did you want to be when you grew up? 
I actually thought I wanted to be a scientist. I thought maybe it would involve medicine (pharmaceutical etc.) which I’ve always been drawn to
Who or what inspired you to become a scientist? 
It was more the topics that inspired me rather than a particular person or my teachers. My inspiration came from a recognition of my own enthusiasm
What do you love about your job and being a “scientist”? 
I’m aware that the ICR is relatively new as a licensing body for the Science Council. I like being at the frontier in clinical research. Most of the chartered scientists at ICR are not involved with regulatory affairs; it’s a niche and I’m quite well suited to it. It’s also rewarding to be involved in the development of new medicines. If new products are introduced to the benefit of patients, that’s a great bonus of this work. Before a medicine is placed on the market it has to pass many checks (quality, efficacy, safety etc). I work with the industry: my role is to help present the information so that it can be assessed properly by regulators. What clinical trials should be done? What laboratory research needs to be done before a clinical trial should start? I work with companies to have a dialogue with regulators, helping the companies establish what they need to demonstrate in order to obtain regulatory approval
What would you change? 
I’d like to be able to just stop turning the pages sometimes and switch off
What qualifications did you take at school? 
Scottish Highers in mathematics, English, French, chemistry, physics and biology. In the last year of school I did sixth form qualifications in applied mathematics, chemistry, physics and biology
Why did you choose your first degree subject? 
Molecular biology at Edinburgh. I found the way the topic was presented very stimulating. I thought there was enormous potential in what was then the new genetics – combining genes, introducing them to cells, introducing them into organisms
Do you have a Masters or PhD? If not, was it difficult to demonstrate Masters-level equivalence in order to achieve CSci? 
PhD in virology at the National Institute of Medical Research
How do you describe your job when you meet people at a party? 
I’m a consultant to industry and I work with the private sector as opposed to the government/regulatory side of activity. I work on different projects with different companies within the area of pharmaceutical new product development
What is ‘cutting-edge’ about your work? 
The field of regulatory affairs is characterized by change. I’ve seen a dramatic expansion in the types of products that are regulated as medicine. There are also new regulatory texts to read and understand whenever I switch on the computer
What are the biggest implications your work will/could have in the future? 
My work contributes to bringing new medicine to patients and extending their longevity or quality of life. Areas I might be involved in include cardiovascular disorders, cancer, haematology, infectious diseases, and immunomodulators. I’m often called upon to help companies with medicines for rare diseases, especially when it comes to developing those products for children. Paediatrics has changed the landscape of the pharmaceutical industry. Historically, when a product is developed for adult use it’s not tested in children. But since 2007 the legislation requires companies to factor potential for use in children into a product’s development
Describe some of the highlights of your average day. 
A lot of my clients are not in the UK and a lot of the companies I work for are smaller companies which ultimately get acquired by a larger pharmaceutical firm. However, people tend to keep their consultants if they can, and maintaining these relationships adds an extra dimension
Describe briefly how your career has progressed to date. 
If the CSci qualification had been around years ago I probably would have taken a more direct career route! When I left university I did a PhD at the National Institute of Medical Research in the UK, then ten years of research as a post-doc in different academic centres in the U.S., UK and Singapore. I found I was dissatisfied that there wasn’t a product at the end of it – the only product was dumped in a library. I found an opportunity in a marketing services company. Their biggest sector of sales was naming products, with70% of sales contributed by inventing new brand names for pharmaceutical products. This is an interesting process involving creativity, linguistics, legal availability of names, and market research into how names are perceived. It involved a lot of cold calling and making new relationships with companies that had a need to develop an identity for a new drug. I was looking for commercial experience and it was a relief to get away from the science for a while. I felt that I was making up for lost time. Next, I jumped fence to one of their clients and started in sales for medical products. This was a role that I did for three different companies in different therapy areas. I learned how different products are brought on to a formulary and how different types of products (both drugs and devices) enter the supply of the NHS. From here, I made a transition into regulatory affairs. I did that for a contract research organization and then moved to a smaller company with more responsibility, which was subsequently acquired by a bigger one. Then I became an independent freelance consultant. Regulatory affairs helped bring my career full circle between sales and science. I can say I’ve worked in the commercial side of the industry which not many regulatory affairs professionals have done
How is your job cross-disciplinary? 
Regulatory affairs tends to be an interdisciplinary profession. You have to be able to understand clinical investigations, manufacturing, and additional legal aspects that influence medicine
How well is your job compensated? What is the starting salary for your field, and how much can this be expected to rise? 
Salaries are monitored across the regulatory affairs sector in salary surveys sponsored by, for example, TOPRA (The Organisation for Professionals in Regulatory Affairs). In companies compensation is related to experience and to current responsibility, the balance being specific to the firm and individual
How do you see your field developing over the next 5-10 years? 
There is an increasingly broad diversity of medicines in development. The future (including how these diverse products will be dispensed in pharmacy) is going to be very interesting
What’s the most unexpected thing about your job? 
What really surprises and delights me is when I get a call out of the blue about something that is interesting because people thousands of miles away have been talking and think I’m the best person to ask. They may be in California, or England, but when they’re far away it’s more remarkable. They’ve identified a particular independent consultant halfway around the world to help them with a product in development
What’s the biggest achievement of your career so far? 
Becoming a freelance regulatory consultant
Would you say you have a good standard of living/ work-life balance? 
I would say I do have a good standard of living. But, work-life balance changes with your time of life and how you feel about yourself. I’m very driven and work long hours but it’s interesting and I can’t tear myself away. I can’t stop turning the pages…I have to read on!
What do your friends and family think about your job? 
I think they’re aware that what I’m doing grips me more intensely than anything I’ve done in the past. They sense that I’m finally happy
What kind of hobbies or extracurricular activities do you do to relax? 
I love music, playing the piano, keeping fit, going running, going to the gym, and I enjoy the garden
Why did you choose to apply for CSci and what do you value most about being a Chartered Scientist? 
I was approached by my previous licensing body chief executive (ICR) in the spring of 2007. He mentioned that a new CSci programme would be starting in clinical research. He saw it as a career track for scientists, either as a way into clinical research or to help them develop further in clinical research. My own career has not been a straight line; if I had seen a CSci programme years ago it might have helped to inform me about various roles in medicine research and development
What is the value of professional bodies? 
They definitely help to reveal the leading edge of change, to increase awareness of what is changing in the regulatory environment of our industry. Professional bodies may help you to understand the impact of changes prior to implementation, to follow the step-wise development of proposed changes before they actually arrive
How important is CPD? What do you think of the revalidation process in ensuring that CSci is a mark of current competence? 
It’s an important aspect because scientific progress and legislative changes can influence the shape of your career. If, by doing CPD, you find a new piece of information particularly interesting it may throw up a career opportunity
Advice & Reflection
What words of wisdom would you give someone interested in getting into your field? 
Look at the trade associations and professional bodies, identify a potential mentor and start to build a network. Building a network and exchanging ideas are very important
How important is the mentoring process in your field and to you personally? 
It is potentially important, especially for young people and those at a transitional point. It’s always exciting to meet someone who’s impressive and accomplished. What they say and what their opinion is can sometimes be thrilling. I’ve had mentors in the past, particularly in regulatory affairs. It’s crucial to be able to switch quickly from one discipline to another (a quality I appreciate in a mentor)
How would you define “professionalism”? 
It’s not only something that you can claim, it’s something that other people recognize, a sense of balance between values that other people can identify with. You’re considered professional if the sense of balance is shared and recognized by other people
What would you do differently if you were starting out in your career now? 
I’ve gained something from all the roles I’ve had, but I’ve stayed too long in some roles. It’s hard to step into the unknown but the more times you’ve done it the more you realize there is a safety net that will never completely disappear in the professional world
What would you like people to remember about your life as a scientist? 
Lifelong learning is important to me
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