The regulatory affairs specialist: a new role for a changing landscape
Emerging in the last few decades, and becoming ever more established in the pharmaceutical industry, regulatory affairs is the profession spearheading safety control. With responsibilities including the evaluation of new research and the implementation of new laws and guidelines, those working in this industry interact closely with those at the very top of business and have an important role to play in the commercial and legal aspects of pharmaceuticals.
Borne from the government’s wish to improve public health provision, regulatory affairs jobs have multiplied exponentially and now include professionals working in fields as diverse as agriculture and beauty.
Development cycles of new pharmaceuticals may take upwards of a decade, with delays exacerbated by ever-changing regulations. The reduction of these delays and the monitoring of changing regulations is a major component of regulatory affairs jobs. With the recent introduction of new GDPR guidelines, regulatory affairs teams are working with companies to ensure their data is compliant, up-to-date, and well-utilized.
The tasks of a regulatory affairs specialist
Within the remit of data and legislation compliance, regulatory affairs specialists may also be required to work within multinational companies, or alongside teams operating overseas. As such, many regulatory affairs specialists will be knowledgeable about guidelines and laws in multiple countries – and how a product has to change to meet multiple sets of regulations. International bodies such as the EU are working to reduce regulatory barriers, but this is still a major aspect of the job for some professionals.
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Marketing products that technically meet regulations may also require input from a regulatory affairs specialist, from advice given to designers about where to locate information on packaging, to assisting with the phraseology of advertisements.
The state of regulatory affairs
A large proportion of regulatory affairs jobs are within contract research organizations (CROs). These contracts may involve working with applications, drafting or publishing reports, or any other functions that prioritize public health and efficient business – a desirable outcome, indeed! The global healthcare regulatory affairs outsourcing market is lower-cost and faster turnaround than many in-house attempts to adhere to regulations, and as such, is increasing in size and value year-on-year. The marketplace is expected to reach a global value of $12.4bn by 2025.
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Compliant and profitable: regulatory affairs and transformation
With businesses continuing to change due to a constant drive to digitize, maintaining that growth is often difficult alongside a need to remain compliant with regulations. Managing customer or patient privacy, transitioning to digital, and operating as separate entities are all characteristics of the life science industry; and an industry that may be lagging behind in terms of regulatory affairs. GDPR, to name the most famous of all new digitized regulations, has meant a far higher workload to achieve the same amount of information. This is a key example of how transparency and data seem to be working at crossed purposes.
See also: the pressures of GDPR on pharmaceutical firms.
For pharmaceutical firms to continue to operate successfully they must seek regulatory approval – yet budgets (and deadlines) have not necessarily extended far enough to ensure guidelines are met. The FDA continues to demand more data, and pharmaceutical companies are often hamstrung by an inability to meet their pre-agreed deadlines.
Regulatory affairs technology
Whilst many companies have been slow to adapt to new regulatory expectations, there is a growing understanding from both regulatory bodies and pharmaceutical companies about how many audits, forms, requests, and email chains everything requires. Intelligent enterprise is poised to transform regulatory processes further, and by utilizing the very best automation and AI technologies, alongside an agile and thoughtful approach to guidelines, regulatory affairs may soon bring global pharmaceutical firms closer together, without the headache.
Are you interested in this topic? Why not read more about regulatory affairs in our regulatory and legal section?