Addressing the regulatory skills gap

Published: 2-Mar-2018

In a role that is so critical to the quality and compliance of pharmaceutical products across the globe, what can companies do to close the growing skills gap?

In an industry in which the demand for regulatory expertise continues to grow and where graduates are entering the workforce with limited to no real-world experience, there is increasing pressure to address a rising skills shortage. The challenges presented by an industry wide skills gap are far reaching; however, professional development organisations are ideally positioned to help fill the void and ensure a skilled, competent regulatory workforce.

The challenge, in full

The regulatory workforce is typically made up of those who possess plenty of experience derived from performing roles in other areas of the pharma sector. Although graduates and younger recruits tend to enter the industry from other career fields, or are entering the profession with excellent academic qualifications, very few of them have the practical competencies required to fulfil the role.

It is also the case that regulatory professionals have seen their role become increasingly strategic in recent years. This calls for the kind of business acumen that is only acquired with time, with professional training in the workplace. Combined, these trends have created a legacy issue wherein businesses are relying on a very experienced and skilled workforce … but need to establish a real plan for succession. The real crux of the issue is the timing; the skills gap is becoming more apparent just as the role of regulatory professionals is coming to the fore as one of the more important cogs in strategic business success.

The reliance on regulatory professionals and their remit is expanding; the pharma sector is in a phase of significant growth, thanks to a wave of globalisation, innovation and expanding product lines.

These changes bring with them broader and more stringent legislative requirements, as well as the need for multidisciplinary strategic input and efficient business practices — all of which fall at the feet of the regulatory team.

Bridging the gap

This generational gap needs to be bridged to meet the current and coming challenges. Experience can’t be fast-tracked; however, professional development programmes — underpinned by global competency frameworks and certifications — can introduce and sustain a prepared, competent and connected global regulatory profession that drives sound regulatory practice.

From a career perspective, regular training and certification attest to a professional’s capacity to learn about new statutory instruments, regulations and the guidelines associated with a variety of products. Importantly, they also must encompass a wider range of competencies, including communication and leadership, to reflect the more strategic role of professionals within their organisation.

The increased reliance on the regulatory profession, as well as the diversity of products and complexity of regulatory definitions, has required training providers to continuously develop their offering to meet the educational requirements of a workforce whose role is rapidly evolving. This also means that even those with plenty of experience in regulatory are well advised to adopt a dedicated approach to professional development.

An instant network

One of the industry’s biggest challenges is globalisation and the increase in the number of regulatory requirements that they must negotiate. Professionals in the sector must be able to interpret and incorporate a knowledge of multiple markets into a launch strategy. Regulatory intelligence is about knowing where to find the answer; understanding the vital regional details is often only possible through a human network. Traditionally, developing a network to meet these needs would have taken time.

Thankfully for graduates and new regulatory professionals alike, manufacturers, marketers and regulators have recognised the benefit of a shared body of sector knowledge, forming societies and associations with a global reach that allow professionals to tap into banks of specialist and regional know-how with increasing ease.


Although there is a skills gap in the regulatory profession, training and certification organisations are well placed to meet current and future development requirements that the pharma industry relies on to continue to advance public health.

The challenge is demanding because the scope of work of regulatory professionals continues to expand; however, a dedicated approach to professional development and the industry’s willingness and encouragement of knowledge sharing will ensure that regulatory continues to flourish.

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