I am responsible for maintaining the pharmaceutical product licences and clinical trial applications with the regulatory authorities. This means I collaborate with people at manufacturing plants, personnel responsible for clinical research and regulatory people at the European head office to ensure that the correct information is registered with the UK regulatory authorities and our products/clinical trials are correctly registered. I also have input into the promotional material that is used by marketing teams to promote product sales. I make sure that we are not making claims that cannot be justified according to our licence.
The day is quite varied and can involve anything from reviewing product artwork, promotional material, submitting variations to product licences so that they are kept up to date and compliant or submitting changes to clinical trials to the UK regulatory authorities.
A large proportion of the day is spent working on your own. There is team interaction between regulatory members to solve particular problems. There is also team interaction when working with clinical research or marketing colleagues and I attend regular meetings held by these people.
This is my first ‘proper’ job since leaving university and since starting 8 months ago I have managed to progress quite quickly, from performing administrative tasks to looking after specific pharmaceutical products.
I have always had a very keen interest in science and was interested in a role that combined the knowledge of science with the commercial world.
Following my PhD I investigated careers in the pharmaceutical industry and spoke to people who worked in different areas. Following this I decided that this area had a good mix of different activities and involved interaction with many different types of people.
University of Bristol – Biochemistry/Genetics PhD
University of Bristol – Biochemistry BSc
Many people who work in regulatory affairs have a background in science – a PhD is not essential.
People are very friendly in all departments and because of the interaction with different departments you get to know lots of different people.
The progression I have made since starting out – especially now that I am looking after specific products.
There are many different specialties in regulatory. My current role is very diverse and I hope to experience the more specialised areas as well as gain understanding of the regulatory environments in different parts of the world
Good time management and the ability to prioritise work load. Also an attention to detail.
Find out what exactly interests you and what you are good at and then investigate the different fields within the industry. Due to the diversity of the roles in the industry if you have a broad interest in science you will be able something that suits you.
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.