Abstract 

Artificial intelligence (AI) is reshaping regulatory affairs (RA) across the medicinal product lifecycle. While AI promises efficiency in regulatory intelligence, dossier preparation, pharmacovigilance, clinical development and manufacturing compliance, it also risks being applied as a blunt instrument for cost-cutting. 

This article reviews current and emerging AI applications in RA and analyses their implications for professionals and organisations. Detailed strategies are presented for new entrants and experienced professionals to develop relevant skills, alongside organisational models for redeploying RA talent and building AI governance frameworks. The discussion situates AI within the global regulatory landscape, explores ethical and harmonisation challenges, and outlines the future trajectory of RA roles. RA professionals can safeguard and expand their influence by embracing AI literacy and governance leadership, while industry leaders must avoid workforce reductions and, instead, redeploy expertise to maximise strategic outcomes.