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Why regulatory affairs is life sciences’ hottest area

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The life sciences sector is experiencing a period of immense growth, with an estimated 25,000 new jobs in the UK set to be created over the next decade.

Emerging technologies are bringing about innovative products and exciting breakthroughs in medicine and science - from gene therapy to stem cell research, mobile medical devices to applications in cloud computing.

Groundbreaking developments make it even more crucial to protect patient health and data, and that’s where the area of regulatory affairs plays such an important role.

Pharmaceutical, biotechnology and medical device companies work in an increasingly demanding regulatory environment, needing to comply with a huge amount of legislation during the development and life cycle of any medicine, medical device or medical digital technology.

EU regulations

Changing EU laws and regulations have made the area of regulatory affairs an even hotter career path within life sciences.

In April 2017 two new EU regulations were adopted to replace the EU Medical Devices Directive, with the aim of bringing a uniform and sustainable regulatory framework across the EU for medical devices - and ensure safety and health standards are high while innovation also flourishes.

And of course, there’s Brexit. Many UK industries are experiencing a period of uncertainty because of the UK’s decision to leave the EU, and the life sciences sector is no exception.

In February 2019 the European Medicines Agency (EMA) moved its HQ from London to Amsterdam. And if and when the UK leaves the EU, it will be harder and more expensive for UK-based life science companies to be involved in clinical trials that take place in the EU.

That’s because European regulations govern the processes a medicine, medical device or medical digital technology goes through during its life cycle and any clinical trials taking place in the EU have to comply with the EU Clinical Trials Regulation.

Although the UK’s Medicine and Healthcare Products Regulatory Agency (MHRA) has published guidance on regulating medical devices in the event of a no deal scenario, many experts continue to call for more clarity on the regulatory environment after Brexit.

All this uncertainty naturally brings more demand for regulatory affairs specialists, as life science companies depend on experts to help them navigate a changing landscape.

Candidates are hard to find

If you have thorough knowledge and sound experience of regulatory affairs in life sciences, we’ve more positive news for you.

A US survey of life science executives and hiring managers in 2018 found that regulatory affairs vacancies are the most challenging to fill. In the ‘Life Science Workforce Trends Report’, 35% of respondents described those roles as either ‘more difficult’ or ‘much more difficult’ than average to recruit for.

That’s something we’re noticing at RHL’s Life Sciences Division, where we’re focused on finding top talent for the pharmaceutical, medical device, biotechnology, clinical research and consumer health (FMCG) sectors.

As regulatory affairs is such a key area, our clients are hunting for candidates with specialist experience of the complex directives and regulations that form the backbone of the life sciences sector. Often there’s just not enough talent around, which is good to hear if you’re an outstanding candidate looking for a new challenge.

With the pace of technological change and new regulations due to come into force over the next few years, this is a situation that’s unlikely to change any time soon. 

Get in touch

If you’re looking for your next move in the life sciences sector, we’d love to have a chat. Get in touch to find out how we can work together.