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The Demand for Regulatory Affairs Candidates

Date: 05 February 2018

Why Regulatory Affairs (RA) candidates are increasing in demand

The accelerated use of technologies in life sciences, such as stem cell research, gene therapy, mobile medical devices, and cloud computing, makes it likely that regulatory uncertainty will continue. Life sciences will need to continue to push forwards effective risk and compliance programs, for example through incorporating cyber security practices to safeguard patient health and data, as well as corporate assets. As this new landscape emerges, more regulatory affairs candidates than ever will be needed to meet the upcoming and unexpected challenges of today and tomorrow.

Demand for RA candidates spikes

Here at EPM, we have seen an escalation in demand for RA candidates in the US over the last year; propelled by the Accelerated Approval provision of the 21st Century Act, as well as an increase in FDA guidance and legislation for medical devices.

Based on the 21st Century Cures Act, in June 2017 the FDA delivered a draft to Congress outlining how they will allocate $500 million to give patients faster access to drugs and medical devices, while maintaining current safety standards, as well as establishing meaningful patient and caregiver input for use in regulatory decision making.

In January 2016, the FDA released post-market guidance outlining its cybersecurity expectations for medical device manufactures already in the field and in the pipeline.

From January 2019, agencies such as Health Canada will require companies to undergo MDSAP audits, knowledge in this area will be essential as companies react to the slow adoption of a global regulatory assessment process.

Complex requires complexity

Let's face it, many organizations are reluctant to hire consultants into permanent positions. There is a stigma that consultants are ‘jumpy’ because they go from business to business and project to project depending on the need. The usual concerns are related to commitment and cultural fit. Even still, advances in technology have driven pharmaceutical companies to spend billions on consulting in 2016 - $1.2 billion to be exact – up 11.9% on the previous year and the highest rate of growth of any industry. Obviously, consultants have the talent the industry needs to progress.

Yet when it comes to hiring ex-consultants into permanent roles, time and time again we find hiring managers and recruiters unwilling to give them the opportunity. They get flagged as poor culture fits, lazy, unmotivated and unwilling to get their hands dirty.

While it is true they do not currently have the day-to-day experience of the average employee —bonding around the coffee machine and at office parties—ex-consultants present an enormous opportunity for businesses. Many businesses assume the reason that a candidate is consulting is because of a decision that they have made. Although this is true in some cases, many resorted to consulting because of downsizing and are now ready to return to permanent positions, bringing with them a wealth of experience.

Given that hiring in the regulatory space can be challenging, many businesses will often choose to bring on a consultant as a short-term fix whist they wait to find the ‘right’ person for the role. Regulatory requirements still need to be met this means that most regulatory professionals who are made redundant or are in-between jobs do not find it difficult to find work on a consulting basis. This can lead to a ‘Catch 22’ situation where candidates find themselves in the world of consulting and unable to break back into a full-time position because businesses have pre-conceived ideas about consultants.

Furthermore, the fact that they could adapt to such difficult circumstances and advance successful careers is something to be admired; flexibility-desirable qualities for working in such a complex and changeable landscape.

Throughout their careers, consultants gain a range of experiences in different markets and industries; allowing them to bring diversity of thought and expertise to a workplace. This diversity is imperative for a company to thrive, studies have shown that diverse groups outperform homogeneous ones, and are also better at risk management.

Ex-consultants also establish a strong network within the industry through dealing with multiple clients and colleague. This network is an invaluable asset to bring to a new position. And it is something that candidates who have remained in long-term positions will simply not have to offer.

Redefining the talent pool

As demand for RA candidates increases, supply dwindles—leading to a tightened market. While here at EPM, we believe that ex-consultants are an attractive candidate choice because of their diverse experience and skill-set, hiring managers and recruiters cannot not afford to consider them because of a talent pool shortage.

The industry trade group Pharmaceutical Research and Manufactures of America (PhRMA) estimates 60% of the industry's jobs could be vacant by 2025 due to the skills and shortage gap.

In 2016, there were only 568,000 STEM graduates in the US compared to 4.7 million in China—presenting the real danger that the country's pharmaceutical industry could fall behind its competitor.

It is also worth considering how the international picture may change if the Trump Administration's protectionist stance leads to tax incentives for pharmaceutical companies to move their overseas productions to the US, generating a greater demand for RA candidates.

For more information on how the recruitment of RA professionals is changing in line with the global regulatory landscape, contact the EPM Scientific team today.