The regulatory affairs role in the pharmaceutical industry is rapidly changing, with many of the tasks once aligned with in-house experts being outsourced or automated by developing technology. This trend is forcing industry professionals to rethink their role and establish themselves as thought leaders who bring measurable strategic value to their company’s business. This insight brief examines the shift of regulatory affairs work to local hubs, which is creating new opportunities for regulatory professionals to work directly with regulators, provide thought leadership input within their respective organizations, and support product development as the profession continues to evolve. Based on market leadership with over 7,000 product registrations serviced in over 150 countries since 2015, this insight brief shares global regulatory affairs insights from IQVIA with partner Bristol-Myers Squibb on the evolution and anticipated future of the regulatory affairs profession and industry.
Introduction: The Long view
Over the past several decades, the trajectory of the Regulatory Affairs function has evolved to its current position at the hub of the development wheel and a dynamic engine of R&D (Figure 1). In terms of outsourcing Regulatory Affairs tasks, we can look back a decade or so to Data Management and Biostatistics functions, which were primarily country- or region-based with similar work conducted in many different geographies. In contrast, today, many staff within these functions are located offshore and are coordinated by global project managers, often based in developed countries. In addition, we are seeing a rapid acceleration of compounds originating outside of the companies ultimately responsible for marketing them. A decade ago, one-third of approved drugs sold by big pharma companies were sourced from outside their organizations. Today, this has risen to between 51% and 70%.
Past And Present
Ten years ago, a regulatory affairs specialist could expect to start out in a role at a company’s headquarters or regional affiliate, working on all aspects of regulatory affairs, covering country- or region-specific projects only.
Today, the regulatory affairs profession is changing as the outsourcing sector matures, and as technologies and processes advance. Regulatory affairs professionals now typically focus on a single sub-process, often working in siloes, and with a risk of not fully understanding the entire scope of product development.