Regulatory Professionals CPIA Report 2018 – Regulatory Affairs Vacancies in EU and UK

This month’s report specifically looks at the Regulatory Affairs sector and notes many interesting occurrences within the levels of vacancies available over the past 12 months and focuses on any noteworthy changes that has occurred.

Clinical Professionals CEO, Yvette Cleland provided her knowledge and insight in this edition’s foreword:

Our regulatory report focuses on how the vacancy landscape is forming across the EU in 2018, and shows the EU 27 are rising with a decline in the UK for regulatory roles. Perhaps not surprising at this time? However as a business we have already seen a turnaround in the last 2 months with a sudden influx of UK/Ireland focussed roles as companies prepare for our Brexit.  As we see the EMA requiring all existing UK based drug assessors to transfer their knowledge to counterparts within the EU member states on completion, we can assume no reliance on any unique UK expertise for leverage with the EU on our specialist and unique capabilities. In saying all of that, the great thought leadership coming from the UK will also be lost.  However, as the Biotech industry continues to go from strength to strength in the UK we are seeing more opportunities opening up for regulatory professionals here with exciting and novel products coming through trials to market which attracts both internal and external talent pools.  We come from a strong base line with 61% growth in the Cambridge market alone in the last 2 years in regulatory affairs vacancies.  Analysing anything thing at this point in time around the UK regulatory function is still confusing.  If we consider that Belgium, France, Germany, Switzerland and the UK are the 5 countries with the highest yield of regulatory roles, only Belgium and Switzerland have seen an increase in activity in 2018 to date. France in fact seeing a 22% reduction in live vacancies versus minus 11% in the UK. The positive shifts in work in a post-Brexit world are attached to Belgium with its proximity to Brussels and the Netherlands as the new home for EMA.  As mentioned though the UK market certainly has picked up over the past couple of months with UK/Ire specialist roles, how the talent pool responds to this we wait to see.  And for new horizons we have the apprenticeship scheme coming into play which we have helped drive through the trailblazer group; this sets up a potential talent ‘goldmine’ for the UK in the future with potential overseas talent export.

However the emerging picture post-Brexit, soft or hard, still sees the UK remaining as a significant market in its own right. Last year in the London region alone, in the face of Brexit, there was nearly 1 billion of investment in life sciences and the sentiment currently remains that companies will inevitably invest in regulatory so medicines can be licensed in the UK/EAA. Perhaps over time we may even get a Swiss type deal, and from my view currently, they seem to have what could be described as a very successful Biopharma industry.

Today however we have limited time for post-Brexit speculation as many companies are rightly focused on business continuity in the face of the current uncertainty around UK/EU trade deals. A “no deal” scenario is looming and the transferring of all European Marketing Authorisations (MAs) held by UK entities that were approved via the centralised procedure, will need to be transferred to an EU based entity by December 2020 on the basis that currently there is no clarity or confirmation of a deal. Companies cannot afford to wait for this to materialise, so have to proceed as if no deal will be there.

The Prime Minister has proposed an option for the UK to have associate membership of the EMA. The details and implications of this need to be worked out and agreed with European counterparts to determine what will remain the same, and what will be different. The EMA will also very likely need support, as they always have done from the MHRA or similar bodies, in the wake of a move and losing pockets of regulatory talent as well as increased workloads, particularly keeping up with new devices and AI products which move at a rate almost no one can keep up with.  If such a deal isn’t secured, then the MHRA will need to identify how to operate as an independent regulator, with patients’ interests and the future of the UK Pharmaceuticals and Life Sciences sector in mind. Ultimately one would hope that at the heart of all negotiations are “people” and therefore the patients and families that could be so profoundly affected.  Let us all hope that regardless of anyone’s’ opinion on the results of the June 2016 referendum that there is no political posturing from the EU around how much needed medicines are delivered to our patients.

To download our Regulatory report please click here

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