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
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.
Browse the latest regulatory affairs jobs