From Compliance to Strategic Partner: The Transformation of Regulatory Affairs in AstraZeneca Local Affiliates.

The role of Regulatory Affairs (RA) within local pharmaceutical affiliates is evolving from a predominantly compliance-driven support function to a strategic partner in drug development and patient access. Traditionally, local RA focused on dossier preparation, regulatory compliance, liaison with national authorities, and maintenance of marketing authorisations, largely executing global plans downstream of clinical development. The increasing complexity of novel therapies (including advanced therapy medicinal products), evolving EU regulatory frameworks, and the broader Medical Affairs (MA) 2030 vision now require RA to be integrated earlier and to operate as a more proactive and strategic partner across functions. This article describes the transformation of local Marketing Companies Regulatory Affairs (MCRA) teams at AstraZeneca (AZ) in Europe, structured around three pillars: (1) Launch Excellence, embedding local regulatory insight into early-asset, launch, and brand planning to support evidence generation, risk anticipation and implementation-ready launches; (2) External Engagement and Advocacy, strengthening strategic dialogue with national Health Authorities and contributing local perspectives to policy discussions on key EU initiatives such as the Health Technology Assessment (HTA) Regulation, New Pharmaceutical Legislation, Clinical Trials Regulation, Biotech Act, Critical Medicines Act, digital labelling, accelerated pathways and adaptive licensing; and (3) Digitalisation and Process Optimisation, leveraging standardised tools, RA platforms and emerging artificial intelligence (AI) solutions to simplify ways of working, improve alignment, and support more efficient submission and lifecycle management. Central to this transformation is "One-Team" Local-Global RA culture of AZ, operationalised through the MCRA Operating Model. Local MCRA professionals are fully embedded in affiliate cross-functional teams while maintaining bi-directional collaboration with Global RA, enabling local insights to inform global strategy and helping ensure that global decisions are implementable at the country level. To monitor progress, a contribution-based measurement framework is proposed, combining quantitative and qualitative indicators aligned with the three transformation pillars and the "One-Team" model. The framework focuses on predictability, launch readiness, environment-shaping activities and organisational effectiveness, recognising that regulatory outcomes result from cross-functional decision making across the product lifecycle. Overall, early and strategic RA involvement, structured around the three pillars and underpinned by a "One-Team" culture, helps accelerate patient access to innovative medicines across Europe.