Working in Regulatory Affairs is one of those “less well known but interesting career options”, particularly if you want to combine technical knowledge with a commercial role.
Regulatory Affairs Officers, Executives and Managers are responsible for pulling together technical, development, quality and safety information on a product, and negotiating with licencing authorities for those products which are regulated. This is particularly associated with the pharmaceutical industry (where critical information needed will also include clinical trials results) but regulated products are also found in the medical devices and chemical industries. The TOPRA (“The Organisation for Professionals in Regulatory Affairs”) website has a good description of what Regulatory Professionals do.
One difficulty, however, is often: how do you get your first post*?
You don’t often see “Regulatory Affairs Trainee” posts advertised, whether at graduate or postgraduate level. I have seen occasional “graduate trainee” posts advertised for the big pharma companies, but only sporadically.
Here are 3 strategies for finding your way into this career:
1. Start somewhere else and move sideways
This is the most common route into regulatory affairs. It’s such a wide role that having an understanding of technical development, or quality, or safety, or clinical trials could give you an awareness of regulatory frameworks and a good foundation to make a sideways move.
For those aiming at the pharmaceutical industry, TOPRA surveyed its members, asking “Please indicate the area of work of your last NON-regulatory job in the pharmaceutical industry”. It’s a really revealing list showing the routes which have led regulatory professionals into their current role. This was a 2006 salary survey in which 127 people replied. At that stage around 17% had entered Regulatory Affairs directly from university, but most had come from research, QA, QC, safety and other regulatory roles before ending up in Regulatory Affairs. Another survey of 200 UK regulatory professionals with between 2 and 5 years experience shows only 10% going into the profession straight from university. (You can see the results on a pdf, from this page on the TOPRA website on career pathways – no date given unfortunately, but the pdf dates from 2010.)
I wouldn’t be surprised if the number going straight from university to regulatory affairs roles continues to shrink. The organisations who traditionally could afford to take a chance and train up new graduates and postgraduates were the big pharmaceutical companies – and look what’s happened to them over the last 10 years. There’s still lots of employment in the pharmaceutical sector but the growth areas are in the smaller companies and contract research organisations who often want some sort of proven knowledge or experience of regulation before taking you on.
Another way of finding out how people got into their regulatory roles is to search LinkedIn profiles. You’ll need your own LinkedIn account to get access to search, and you’ll get more information on individuals’ career paths if you have some sort of connection with them (1st or 2nd degree ie you know someone who knows them; or if you are in the same group). It doesn’t mean you can randomly send out job requests to anyone you find but it could give you some ideas of alternative starting points.
2. Broaden your search terms
I searched the scientific and health jobs we’ve advertised through CareersLink over the past year, using the term “regulatory”, and found we’d advertised more jobs related to scientific regulation than I’d expected. Most of the posts working within scientific product regulation weren’t called “Regulatory Affairs Officers” or trainees. They were often safety, quality, technical or experimental officer roles – but when you read the descriptions, they could give you the experience you’ll need to make the move into a purely regulatory role later.
3. Be prepared to start at the bottom
If you haven’t got the experience needed to go straight into a regulatory affairs role, and someone else isn’t prepared to invest to retrain you, you have to decide if you’re prepared to invest in yourself.
Unless you’ve already got experience in a related role, you’re essentially a career changer, and most career changers have to move backwards to ultimately move ahead in their new career. (I know a bit about this. When I moved from a senior management role in industry to a trainee careers adviser, it took me 7 years to get back to my original salary – but I have absolutely no regrets.)
Regulation involves a lot (and I mean a lot) of admin and documentation. You may feel your PhD prepared you for more than a job generating and organising quality or safety documentation relating to regulatory control, but when you’re a senior Regulatory Consultant on ~£100K, responsible for Western Europe or Asean markets, you’ll look back and realise that investment was worth it.
Here are a few other online resources for would-be regulatory affairs professionals:
NB. I wouldn’t recommend relying on either of these agencies (or others) for finding you an entry level post in regulation. Specialist agencies can be great once you’ve got experience. However, they’re unlikely to be very interested in you if you’re looking for a career change (why would a company want to pay an agency a fee to find someone with no relevant experience?!).
* This was partly in response to a question from “Weebz” on our Feedback page (thanks – hope it answers your query) but it’s a question I’ve been asked by several scientific postgrads when they’ve discovered that this sort of career exists.