The satisfaction of knowing that, because of your work, a medicine couldn’t be any better is huge. And the variety of challenges makes it unique.
Regulatory Affairs is the real safeguard of the pharmaceutical industry. Given the large amounts of legislation which make sure that a new treatment is as effective and free of risk as possible, a career here allows you to help drive the development process forward, so that a medicine reaches the market quickly. And by offering advice that could help reduce misuse and dangerous side effects, you can be as much of a lifesaver as the medicine itself.
Involvement begins as soon as a new drug is discovered and continues long after the finished product reaches the shelves of the local chemist. There are stringent testing requirements set by governments worldwide at every stage of this process, which must be met by comprehensive and accurate information on top of convincing analysis and results. So before the documentation required by the regulatory bodies (sometimes up to 50,000 pages) can be submitted, it’s down to the people in regulatory affairs to keep track of the changes in legislation and to make sure that the right tests have been done, at the right times, with the right interpretation of results.
All medicines on sale in the UK have been granted a Product Licence, either through the UK Medicines and Healthcare Regulatory Agency (MHRA), or via the European Medicines Agency (EMA) which grants a licence for the whole of the EU.
Even when a licence to sell a new treatment has been granted, the work doesn’t end there. It’s a huge responsibility to make sure that the medicine’s packaging is accurate and lets the patient know about potential drawbacks as well as the benefits they can expect. And, once it’s on sale, adverse events must be monitored, and variations to the licence applied for.
A real advantage of a career in this area is that you get a holistic view of a drug’s development. And by liaising with so many different people, from drug development teams through to people in marketing and legal affairs, as well as external health authorities, you serve as a lynch pin – holding the whole operation together.
People who work in regulatory affairs
Because being able to understand and construct scientific arguments is such a crucial part of any regulatory role, a background in science is a prerequisite. Occasionally people join the industry straight from school and work their way up from an administrative role, but the vast majority of new recruits come from university. A PhD can be useful, in terms of the experience and authority it gives you when arguing or defending a point, but it’s by no means essential.
There are lots of different roles and plenty of variety across the different sectors of the industry. Typically graduates might enter into a role as a Regulatory Affairs Officer/Scientist/Executive. Regulatory Executives create submission documents from early phase clinical submissions through to marketing applications for regulatory authorities worldwide. Regulatory scientists support global management of prescribing information through out the product lifecycle including development of Core Safety Information and the Global Datasheet.
To begin with, the work you do is often designed to familiarise you with your company’s product range and legislation. It could involve preparing documentation for licence renewals (looking at the market to see if changes need to be made to regulatory information about the medicine) or helping with the information for the Summary of Product Characteristics. You’ll be expected to pick things up quickly and shouldn’t be scared of responsibility. But with the training that’s widely on offer, both internally and externally, you can develop your skills at a rate to match everything that’s demanded of you.
If you’re the sort of person who’s interested in science this could be the area for you. To be successful you’ll need a host of different skills, none more important than the ability to communicate both face to face and on paper. Tact and diplomacy are also essential when challenging ideas and methods to argue a case.