A Call To Action: Developing an Agile Global Regulatory Affairs Workforce for the Future
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.
Authors
- Elizabeth P. Reilly (ORCID: https://orcid.org/0009-0005-1100-0852)
- Max Wegner
- Sean Curtis
- Michael R. Garvin (ORCID: https://orcid.org/0000-0002-2204-7569)
- Nawar Latif (ORCID: https://orcid.org/0000-0002-2908-5330)
- David C. Isom
- Kathy Williams (ORCID: https://orcid.org/0000-0002-5936-1340)
- Donna Boyce
- Kevin Carl (ORCID: https://orcid.org/0000-0003-2572-5289)
- Fabio Bisordi
- Michelle Rohrer
- Amy Bertha
- Lina Aljuburi
- Mark Taisey
- Katrin Rupalla
- Jennifer Dudinak
- Carlos Garner
- Sabine Luik
- Raymond C. Votzmeyer
- Nicole Mahoney
- Virginia Beakes-Read
Institutions
- AstraZeneca (United Kingdom) (GB)
- Roche (Switzerland) (CH)
- Novartis (Switzerland) (CH)
- Merck & Co., Inc., Rahway, NJ, USA (United States) (US)
- Amgen (United States) (US)
- Johnson & Johnson (United States) (US)
- Bristol-Myers Squibb (Germany) (DE)
- Eli Lilly (United States) (US)
- Pfizer (United States) (US)
- AbbVie (United States) (US)
- Sanofi (France) (FR)
- Bristol-Myers Squibb (Sweden) (SE)
- Takeda (United States) (US)
- GlaxoSmithKline (Germany) (DE)
- AstraZeneca (United States) (US)
- Bayer (Germany) (DE)
Publication Details
- Journal
- Therapeutic Innovation & Regulatory Science
- Published
- 2025-12-05
- DOI
- https://doi.org/10.1007/s43441-025-00877-w
- Primary Topic
- Biomedical Ethics and Regulation
- Type
- article
- Field-Weighted Citation Impact
- 0.00