As industry regulations and business dynamics are constantly changing, the role of regulatory professionals in the pharmaceutical sector has needed to evolve in recent years
In the late 1990s, regulatory affairs as a dedicated profession was still relatively new, with a non-standard career path and limited educational support. Regulatory professionals invariably had experience in the industry and viewed the discipline as one of any number of logical next-steps in their personal development. In short, people fell into the profession rather than chose it.
Years of increasing regulatory obligations, more complicated products and the opportunities presented by globalisation and technological developments have created a crucible for the profession to forge itself in. Following a hike in a reliance on regulatory professionals for strategic input during recent years, the role has stabilised and become well defined — with the training and education that underpins recruitment and career progression broadening and becoming more formalised.
There remains a trend for regulatory professionals to move into their roles and respective departments from other fields. The biennial Scope of Practice and Compensation Survey of the Regulatory Profession, conducted by the Regulatory Affairs Professionals Society (RAPS), found that more than 88% of respondents began working in another field before moving into regulatory, often with significant work experience under their respective belts, and largely coming from the bench sciences or engineering.
The 2016 survey also found that an emphasis on higher education is prevailing, with more than 99% of participants holding a university degree. One trend that not only goes to highlight the expertise to be found in regulatory — but the growing complexity and reliance on the profession — is the ratio of post-graduate qualifications. Of those surveyed, more than 42% hold a Master’s degree, a 2% increase from 2014.
Continuous development is vital in a sector in which the goalposts are constantly moving and opportunity for growth and improvement is limited by ambition alone. As a result, there is a growing trend towards regulatory professionals taking control of their own learning and seeking to develop the core competencies required to ensure regulatory excellence and advance in the sector. This demand has fuelled the development of the industry recognised Regulatory Competency Framework (RCF) and the growing uptake of the Regulatory Affairs Certification (RAC), the only post-graduate certification in regulatory affairs. Holders of the RAC have demonstrated a command of the core competencies required to succeed in an increasingly complex sector.
Another challenge that regulatory has overcome since its inception as a distinct profession is scale. As the path to globalisation widens and product portfolios bulge with variety, regulatory professionals have had to develop an array of skills to deal with multinational workloads across numerous product types.
So dominant is the international nature and product diversity of the work that only 7.2% of respondents reported that their role focused on a single country; nearly three quarters were involved with multiple types of products.
Perhaps the most dramatic shift in the regulatory profession has been the growing influence it has come to have on a company’s strategic focus. Long gone are the days when regulatory departments were responsible for just submitting things and getting them approved. In addition to the fundamental research and development, clinical testing, product registration and other preapproval tasks, regulatory is spending more time on strategic activities.
This strategic reliance has grown organically as the pharma sector has replaced a relatively insular structure with a pod structure made up of villages of interconnected stakeholders, and regulatory has found itself uniquely placed to engage with all of them. Regulatory professionals interact with every department — from research and development teams, manufacturing and quality all the way through to marketing, sales, legal, finance and management teams, along with clinicians and consumers.
The scale and depth of multidepartmental understanding afforded to regulatory means that it is more equipped to understand the challenges that stakeholders at all levels face. Today, the expertise offered by regulatory professionals is regarded as an invaluable business asset. Their education, skills, experience and effectiveness as business leaders are now prized in equal measure.
The remit of regulatory has grown to such a level that these professionals can have a real impact on both their employer’s businesses and the patients who ultimately benefit from healthcare products.