The Demand for Regulatory Affairs Candidates

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 forward effective risk and compliance programmes, for example through incorporating cybersecurity practises 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 Scientific, 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. In September 2023, the FDA issued the final guidance titled "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions," providing updated recommendations on cybersecurity considerations for medical devices.

From January 2019, agencies such as Health Canada will require companies to undergo MDSAP audits, and 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 organisations 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, meaning 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 are 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 is a desirable quality 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, with studies showing 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 colleagues. This network is an invaluable asset to bring to a new position, and is not something that candidates who have remained in long-term positions will be able to offer.

Redefining the talent pool

As demand for RA candidates increases, supply dwindles—leading to a tightened market. At EPM Scientific we believe that ex-consultants are an attractive candidate choice because of their diverse experience and skill-set, and that they should be considered by hiring managers, particularly considering the high demand for skilled professionals.

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. For instance, a 2022 report by the Association of the British Pharmaceutical Industry (ABPI) highlights the need for more experienced staff with strong digital skills to ensure the future success of UK life sciences.

China continues to lead in STEM education, with over 40% of its college graduates majoring in STEM fields, compared to 18% in the United States. This substantial output has propelled China to the forefront of science and technology metrics in recent years.

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.