Mahoney, Nicole, Carl, Kevin, Nahid, Latif, Votzmeyer, Raymond C., Taisey, Mark, Williams, Kathy, Wegner, Max, Dudinak, Jennifer,, Garner, Carlos, Luik, Sabine, Rupella, Katrin, Curtis, Sean P., Boyce, Donna, Rohrer, Michelle and Reilly, Eddie (2025) A Call To Action: Developing an Agile Global Regulatory Affairs Workforce for the Future. Therapeutic innovation & regulatory science. ISSN 2168-4804

Abstract

As leaders of biopharmaceutical regulatory affairs organizations, we must learn from the past, thrive in the present and strive for an even better future. We understand the strategic role regulatory affairs professionals play in biopharmaceutical companies, one that uniquely spans the entire continuum of drug development. Our professionals must navigate the increasingly complex regulatory environment, strengthening company engagement with global regulators and other stakeholders to successfully deliver innovative products to patients. Our organizations are only as strong as the people on our teams. As the future of therapeutic development changes in response to technological and scientific advances, we have an obligation to develop, recruit and retain top talent, and build a competency framework to not only meet today’s demands, but to better equip the workforce of the future to improve patients’ access to treatments. There is a great opportunity before us–upskilling our current professionals, attracting individuals with a diversity of expertise into the profession, and setting up the next generation for dynamic and successful careers. This is a call to action for professional societies, academic organizations, regulators, biopharmaceutical companies, and other interested stakeholders to prepare and develop the Global Regulatory Affairs workforce of the future.

Item Type:	Article
Date Deposited:	17 Feb 2026 00:45
Last Modified:	17 Feb 2026 00:45
URI:	https://oak.novartis.com/id/eprint/56375