There are generally two enablers for people to enter a profession. Firstly, candidates need to be made aware of the profession and the roles within it and, secondly, they need to be able to secure a position based on their skills and experience. Anecdotal consultation with existing regulatory professionals, in addition to students and those looking to transition into regulatory affairs at later points in their career, suggests room for improvement within regulatory affairs.
Many individuals may not know that regulatory affairs exists as a career, or they may have a general awareness, but do not fully understand what it entails. For those who have made a conscious decision that it is a profession they would like to pursue, they often face considerable challenges securing work experience or a full-time position. As such, it is worthwhile considering opportunities to increase accessibility.
Individuals may not know that regulatory affairs exists as a career, or may have a general awareness, but do not fully understand what it entails.”
It will not come as a surprise for those who work in regulatory affairs when people claim that they “stumbled into” the profession. Typically, this may be a result of working in another part of an organisation and interacting with the regulatory team, before transitioning across to a dedicated regulatory role. It is rare to come across someone who has proactively pursued regulatory affairs from the outset. However, there are occasions that may offer the chance to spark early interest in regulatory affairs. For example, those in their network working in regulatory who tell them about it, or perhaps hearing about regulatory affairs at a university lecture or careers event. However, these occurrences are infrequent.
Regulatory affairs could, therefore, benefit from positive promotion to raise awareness to a more diverse audience, and attract top talent with the required skill sets to a regulatory career. Strong career performance can be rewarded with large scope for development, either by diversification or specialisation, and good job security due to the high demand for regulatory professionals.
One method of attracting new people into the profession is through events like career fairs. For example, TOPRA's Regulatory Careers Live event enables delegates to attend presentations to learn about a day in the life of a regulatory professional, what skills are required, and provides advice for applying to roles. It is exciting and encouraging to see the growing number of attendees to this event as it could indicate that people are not just “stumbling across” regulatory affairs but taking proactive measures to find out more and work towards attaining a regulatory position. Every year, a variety of recruiters attend Regulatory Careers Live and offer advice to attendees about getting into regulatory roles or advancing their careers.
Additionally, the New Regulatory Professionals (NRP) Special Interest Network (SPIN) at TOPRA has also been involved in promoting the profession through interactions with membership organisations and educational institutions over the past few years, such as the European and British Pharmaceutical Students’ Association (EPSA and BPSA, respectively), the Danish life sciences programme Synapse Connect, and universities such as Warwick, Aberdeen and Liverpool John Moores in the UK. These interactions have forged new relationships and expanded existing TOPRA links. Within the pharmacy student community, regulatory affairs appears to be relatively well known and understood, but is rarely mentioned within other degree streams such as biology and chemistry, which would also offer potential candidates for regulatory roles. A key driver for improved awareness of regulatory affairs is making it a more familiar career path to those within further education.
Every year, a variety of recruiters attend Regulatory Careers Live and offer advice to attendees about getting into regulatory roles or advancing their careers.”
Opportunities to gain experience
The subsequent challenge, once awareness about the profession is increased, is ensuring that proficient and enthusiastic candidates are able to secure a role. There are well-constructed routes, for example, via undergraduate “sandwich-year” placement programmes. However, these are often highly competitive since there are not many placements available. Less formalised work experience, arranged on an ad-hoc basis such as shadowing a regulatory professional, often may require you to know the right people. Without being able to gain some form of work experience, the likelihood of being able to secure a full-time role is less promising. This is because even entry level roles often demand one or two years of experience. The irony is that employers are asking for people to have experience to be eligible for the role, yet they do not often give people a chance to gain the requested experience. However, schemes such as the recently launched regulatory affairs specialist apprenticeship are aiming to help resolve this issue.
The standard was created by professionals working in a variety of organisations covering pharmaceuticals and medical devices, and the first intake for the TOPRA apprenticeship training started in the summer of 2019. The apprenticeship allows regulatory teams from organisations based in England that pay the apprenticeship levy to benefit from those funds. For example, organisations can take on new staff or use the levy to develop staff they already have on their team.
Levy-paying organisations based in England can use the levy to fund the training of current or new staff. Since 2020, the UK government allows non-levy payers (including small and medium-sized enterprises) to be able to access 95% of the cost of the training. For employers outside England, the apprenticeship standard and assessment plan is a useful resource to guide the training of new staff to a recognised standard.
Being a member of a professional body is a great way to demonstrate commitment to professionalism and working in the profession, for example, demonstrating commitment to continuing professional development through reading professional journals.”
On an individual level, there are things that can be done to increase a person’s chances of attaining a regulatory affairs role. As regulatory affairs becomes more popular as a career choice, the competition for placements, graduate schemes and apprenticeship, as well as full-time positions, will inevitably increase. Demonstrating an understanding and awareness of the profession is an advantage when applying for roles, particularly for students trying to secure work experience. Being a member of a professional body such as TOPRA is a great way to demonstrate commitment to professionalism and working in the profession. For example, demonstrating commitment to continuing professional development (an example of professionalism) by reading editions of Regulatory Rapporteur, attending training courses, or joining a variety SPIN groups as a forum for networking, discussions, asking questions and furthering understanding. Since regulatory affairs is important in every aspect of product development, candidates may have already been involved in some form of regulatory-related activities. Realising these transferable skills and bringing to the forefront all such activities can add experience and further understanding about regulatory affairs, as well as providing additional evidence of the required skill set.
We can all promote awareness of regulatory affairs and advocate it as an exciting, dynamic and rewarding profession. However, the value of encouraging people to join the profession is much greater when there are realistic opportunities for them to attain a role. Once in the profession, personal and role development becomes a lot simpler, and this can provide reassurance, particularly when coupled with advice on the training programmes, internships and apprenticeships that are routinely offered by many organisations to fuel the profession with fresh new talent, and to ensure there is a positive opportunity for succession planning. Every interaction, however small, with potential new talent makes additional people aware of regulatory affairs and may spark the interest of a few more bright minds.
Acknowledgements: Arunima Chatterjee, Clinical Quality Officer, Digital Healthcare transformation and compliance, Doctorlink, UK, and TOPRA NRP SPIN Steering Committee members, for assistance in reviewing this article.