An SEC view on the regulatory affairs market

An experienced professional with over a decade of experience within the Life Science industry, Mark Wilkins gives uMark 1_Allys an insight in to the latest developments that he’s seen in his time talking to some of the biggest players in the field.

Give us a brief overview of the types of positions that you work on and the types of individuals you work with.

In my time working on this market, one of the things I have grown to love about it is the varying nature of the types of roles that exist. What I’ve certainly seen in my time is a large variety of senior roles, associate director positions and certainly there is always demand in CMC and clinical focused positions. Many of the pharmaceutical and biotech organisations we speak to want to focus on strategic positions and product life cycle development but what struck me when I started working in to this market was the sheer variety and depth of knowledge of the people I spoke to. The types of people I speak to on a daily basis sometimes have anything from five to 30 years’ experience and the demand for this type of knowledge and skill set is massive. The types of roles we have vary from local to global level. .

Where do you see demand from employers you currently work with?

We have had plenty of demand from big pharma and our client base is growing, but what we’ve started to see – and where I certainly think the market is moving – is towards smaller/medium biotech’s. We’ve also seen an increase in demand from consultancy companies too. That is certainly where our focus is at the moment. These types of smaller agencies also generate interest because they can be really interesting places to work. They produce interesting products and that’s where a lot of candidates are looking at too.

What does the perfect candidate look like to a lot of the employers you work with?

Authors and writers of clinical trial applications, or marketing authorisation applications, with line management experience. They would have operational skills with global experience too. Employers are often looking for people who have experience in delivering strategy and if you have a big pharma background then you would definitely be in demand. If the person has worked for a consultancy, then that’s fantastic, but the biggest area of demand for talent that I’ve seen is Advanced Therapeutic Medicinal Products  (ATMP), which includes the biologics. If you have that type of experience in the market then you will be a very sought after person and I’d definitely like to talk to you! Either from a CMC or clinical perspective. Biotherapy is also an area where there is plenty of demand for.

What’s your experience of good candidates in the regulatory affairs market?

People working in the regulatory space are very outgoing. They are incredibly intelligent and are rarely introverted. The best candidates are fantastic negotiators – which you’d expect given that they have to deal with health authorities – and they always have personality. Some can be very technical, like the CMC guys you talk to, but all are very personable people.

What does the regulatory affairs market look like in ten years’ time?

That’s a very difficult one to predict. There’s no doubt the biotech revolution is happening, the med device revolution is happening, which is where the regs market will be. The world is becoming more regulated and we’ll need more experts to be part of that. These people will be at the forefront of making sure that medical devices, and biologics are safe. Medicine is becoming more personalised and the revolution of DNA profiling for medicine is something that is not inconceivable in the distant future. From a regulatory affairs perspective, the future is certainly looking bright.