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Pharmaceutical Medicine

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

This article describes the transformation of AstraZeneca's local Marketing Companies Regulatory Affairs (MCRA) teams in Europe from a predominantly compliance-driven support function into a strategic partner in drug development and patient access, organized around three pillars (Launch Excellence, External Engagement and Advocacy, and Digitalisation and Process Optimisation) and a "One-Team" local-global regulatory culture, and proposes a contribution-based measurement framework to monitor progress.