Regulatory Affairs Executive

Kelsey

Senior Regulatory Affairs Executive

My initial role was a massive learning curve as I got to grips with the industry and the technicalities of a role in regulatory affairs. Kelsey

So, what do you do?

I am responsible for the regulatory activities for the company I work for in the UK, Ireland, South Africa, Australia and New Zealand.  Practically, this means keeping Marketing Authorisations (which allow companies to sell medicinal products) in these markets up-to-date with current safety, efficacy and quality information.  In the UK and Ireland, I have a hands-on role with the submissions, whereas regulatory staff are based in the other three countries.  As the regulatory contact for these markets, it is my role to provide general advice to the company on regulatory issues that affect our products.

What does your typical day involve?

Every day is different. What I have planned for one day can easily have changed as soon as I sit down at my desk depending on what emails or post I have received.

However, in a nutshell, typical regulatory work involves preparing variations to product licences which will update usually safety or quality information.  The licences also need to be renewed after five years, and again regulatory prepare those submissions.  In fact any contact between the company and the regulatory agencies, such as the MHRA or IMB, is lead by regulatory staff.

Other day to day activities include providing regulatory advice to commercial teams or to the manufacturing site on the feasibility and impact of potential licence changes, or providing local advice on the submission of potential Marketing Authorisation Applications.

Do you work mostly on your own or as part of team?

Both.  As the only regulatory person responsible for the UK markets much of my work is on an individual basis.  However, I am based within the regulatory department and my role is part of the UK team giving me an insight into two different sides of the business.  In addition, there are many project teams set-up depending on the different business needs and I participate wherever appropriate.

How has your career developed since you entered the industry?

I entered the pharmaceutical industry with no previous experience of regulatory affairs or the industry.  My initial role was a massive learning curve as I got to grips with the industry and the technicalities of a role in regulatory affairs.  Since then I have had roles with increasing responsibility over products in UK and Ireland, and now with three more countries,

Why did you decide on a career in the pharmaceutical industry?

It is something I have always been interested in.  I was always scientifically minded at school and drawn to how medicines work on the body and what they do.  Studying pharmacy seemed like a natural step even though I didn’t necessarily want to be a pharmacist practising in the retail or hospital environment.

The pharmaceutical world had always interested me and this was confirmed at university when I took industrial related modules (and not just the lab based ones) and spoke with lecturers who had industry experience.

What qualifications and experience did you have when you entered the industry?

I studied for a Pharmacy Masters degree at Nottingham University and then undertook my pre-registration year at one of the local hospitals.  After qualifying, I stayed on at the hospital as a basic grade pharmacist gaining a wide range of experience I still utilise now.

Currently I am studying for an MSc in Regulatory Affairs which is run by TOPRA (The Organisation for Professionals in Regulatory Affairs).

Do you think additional qualifications or experience would be an advantage for someone entering the industry now? What might be valuable?

My practical hands-on experience as a ‘customer’ of the pharmaceutical industry has been invaluable, as has my pharmacy undergraduate training.  I was able to start in regulatory affairs already knowing about the products and the steps involved in the drug development process.  I didn’t have to worry about how to say the drug name or get my head around what they did.  In comparison to other new starters entering this field, all I had to focus on was the regulatory guidelines and legislation, although this is still a massive amount to learn!

Do you work mostly on your own or as part of team?

Both.  As the only regulatory person responsible for the UK markets much of my work is on an individual basis. However, I am based within the regulatory department and my role is part of the UK team giving me an insight into two different sides of the business. In addition, there are many project teams set-up depending on the different business needs and I participate wherever appropriate.

What is it like socially where you work?

Although I have only been here a short while, so far there seems to be a good social network. I am told that my business unit encourage singing at the Christmas party but I am as yet to experience that. For those of a more sporting nature there is a lunchtime running club and I am sure other sporting clubs could be set up if you find yourself with a like-minded person

What are you most proud of in your career?

Having the confidence to change careers from hospital pharmacy to working within the pharmaceutical industry.

What possibilities are there for your career in the future?

It really depends on what you want. You could take a path towards a more strategic development role supporting the licensing of new products or explore working within new markets, e.g. the US and Japan. Within regulatory, there are a number of disciplines in which you could specialise. Line management and eventually running a regulatory department is another possibility. The one thing I can guarantee is that regulatory is an ever-changing discipline and I can’t imagine getting bored.

What do you think are the most important skills for someone in your role to have?

Regulatory is the company voice when dealing with health authorities so excellent communication skills are a must, both in a verbal and written form.

Negotiation skills and the art of persuasion, are related to good communication skills as regulatory quite often have to persuade or negotiate with someone (both externally and internally) to get something that quite often isn’t on offer. Through good communication, complex regulatory requirements or guidelines can be translated and regulatory advice provided to internal colleagues.

What one piece of advice would you give to someone seeking a career in the pharmaceutical industry?

Apply!  And keep applying until you find an opening you want.  Although many people believe that you need previous experience or a higher degree to get a place within industry, it is possible without. I had no previous experience and no further postgraduate qualification but I found a role with a company looking for new starters. Companies do have openings for recent graduates and are prepared to invest in training and development but the only way you will find these jobs is by applying.