It’s not all doom and gloom if you want to get into regulatory affairs

No company can succeed these days unless it has a really good regulatory affairs department. This hugely important, but rather misunderstood, function sits at the interface between the company and health authorities and acts as the contact point for regulatory agencies regarding a company’s product.  

As a regulatory affairs professional you have to not only understand different aspects of product development, but also be able to provide input on how data can be used to support registration in numerous countries. This also means spending a lot of time in keeping up to date with changes in regulations in different markets. Nowadays, while an understanding of the regulatory agencies of the US, EU and Japan is still key, you may find yourself dealing with markets further afield such as China, India or Brazil.

As the regulatory affairs function has a multidisciplinary element to it there seems to be no set route into roles in the profession. For an interested newcomer it can be quite confusing to work out where to start to enter this field, particularly since it is changing all the time. Unfortunately, many people you meet working in regulatory roles come from such diverse backgrounds that their career path might not work for you.  As a job seeker, you can feel quite disappointed because there seems to be a general lack of interest in people who do not already have regulatory experience.

Thankfully, the area has grown so much in stature within the healthcare sector that there are now professional organisations to help regulatory professionals. Two such useful organisations are The organisation for professionals in regulatory affairs (TOPRA) and the Regulatory Affairs Professionals Society (RAPS). They are playing an increasingly important educational and networking role. Both these organisations actively seek to promote regulatory affairs as a profession and so are good places to figure out if this area is for you and help you develop your career. They have courses to give you a solid foundation in regulatory affairs and also run conferences where you can hear from senior regulators. Another useful organisation is the Drug Information Association (DIA).

General news websites running articles and news, and the websites of the major regulatory agencies are great places for self-education. While some information is highly technical and aimed at specialists, a lot is clearly introductory with the intention being to demystify what goes on. You would be surprised to see what sort of information they have – for example, the FDA has a fascinating section on its history which helps you understand exactly why the regulatory affairs profession has evolved to become what it is today. Also both the FDA and EMA manage a number of social media channels.

If you want to get into regulatory affairs you need to be both self-motivated and proactive to make headway.  The route might not be straightforward but there is a lot you can do for yourself.

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