The regulatory affairs environment is rapidly transforming, with many tasks
once handled by inhouse experts now outsourced or automated by developing
technology with the use of optimised processes. In light of these changes,
regulatory professionals need to redefine the strategic value they bring to an
organisation and develop or hone new skills to make themselves indispensable for
Three areas will continue to be in demand regardless of technological advancements: project management skills, specific expertise and relationships with regulators.
Project management is now essential across every aspect of the product development and management lifecycle, including regulatory affairs. Regulatory professionals who demonstrate strong leadership and communication skills and can engage stakeholders and manage risks will continue to be in demand. Pursuing project management training, certification and experience will add value to their CVs and career prospects.
While having a thorough grounding in all aspects of regulatory affairs is the baseline, to stay competitive, regulatory professionals need to develop additional specialisms in an area of interest to patients, regulators and other key stakeholders. That expertise can range from therapeutic areas, regulatory subsets (CMC, clinical, etc) and/or technology. Whatever the area, it is important to become an expert by learning as much as possible and demonstrating that expertise through presentations, project participation and stakeholder interaction.
Because regulatory work is still largely localised with respect to agency interactions, this provides opportunities for thought leadership input for staff within their respective organisations. To make the most of these opportunities, regulatory professionals should focus on expanding their relationships with regulators and establish themselves as key liaisons between the organisation and the regulatory bodies.
Change is always challenging, but if regulatory professionals focus on the core value they bring to their employers, they can build a long, successful and rewarding career regardless of their geophysical location.