The Perfect Storm of Regulatory Affairs

In over 15 years of head-hunting within the Health & Life Sciences market I have never known a time where demand for Regulatory Affairs professionals has been so high.

The perfect storm of regulatory changes, an abundance of R&D activity creating new drugs and products that require approval, and the increasing reliance by companies to outsource to regulatory consultancies has led to a niche war for talent in this area.

There are some great outsourced agencies in the market able to handle one-offs or small projects for clients who don’t need an inhouse regulatory professional, but what about when that company is going through rapid expansion with multiple product / drug launches, the costs of outsourcing become eye-watering.

What about if a company isn’t quite receiving the service they need from their outsourced provider? Perhaps the company has been bumped down the priority list as the service provider has more interesting or lucrative approvals from other clients? And what does all of this mean for the immediate and longer-term talent in this sector?

Perhaps it is worth first considering this from a “CANDIDATE” perspective. Regulatory Affairs is a niche and important department for any Health & Life Sciences business. In the past it has been viewed as a profession somewhere between Quality & Legal. The detail focussed, and sometimes insular nature of the work, has perhaps led the function to be considered a necessity of the business rather than a key department from where strategic ideas are initiated. Furthermore, the increased inclination of companies to outsource the work to a “specialist” has somewhat compounded this notion.

Several years ago, RMG was tasked with recruiting a Director of Regulatory Affairs for a medical device SME and something has stuck in my mind from the briefing received from the company’s CEO which I think is helpful to share.

The candidates needed not only to show the CEO that they can do the job, but they also needed to demonstrate and prove what broader value a senior Regulatory Affairs professional could bring to the business.

I wonder whether in hindsight the conversation and expectation needing reversing. For someone who was going to bring such an obvious and tangible value to the table. The company in this example was sitting on c.£40m of annual commercial value based on its R&D pipeline - value that would amount to nil, less also the cash burn associated with the R&D, if the products didn’t secure the correct regulatory approval. Where was the onward career progression coming from for the person who was going to come in and make their pipeline a commercial reality?

Whilst larger players in the Health & Life Science sector, with more attractive employer brands are easily able to pull regulatory professionals into their orbit or indeed have a greater ability to second and develop professionals from other functions into a Regulatory Affairs role, where does that leave the SMEs in our space who simply don’t have the same pulling power as larger corporates?

Perhaps the question, and true thinking behind this piece, lies more at the door of regulatory professionals themselves. What are your longer-term motivations and goals of working directly for a manufacturing or drug/product development company? What it is that keeps you engaged in an organisation when there is an inordinate amount of lucrative (albeit timestamped) consulting opportunities either to go out under your own steam, or to work for one of the many consulting houses?

We are actively looking for Regulatory Affairs specialists…

RMG has a select number of growth minded clients in the Health & Life Sciences space, many of which are actively interested in developing their Regulatory Affairs function and making it a central feature in their growth plans.

I’d be delighted to hear some feedback (in confidence rather than public forum – unless you prefer the latter) from regulatory professionals in these markets about what it is that truly motivates you to carry out an “in-house” Regulatory Affairs role, and also what career development aspirations you would have to reward the great work that you do.

Regulatory Affairs is such a hot topic for headhunters at the moment - we would really appreciate hearing your views from both candidates and clients. You can connect with us via hello@rmg-uk.com or call us on 01928 711 800.