Scalability of Digital Transformation in a Highly Regulated Environment: Lessons From Roche's Global Operations

ABSTRACT

This practitioner paper examines how multinational organisations can scale digital transformation in highly regulated environments where compliance requirements vary across countries and functions. While many organisations successfully launch digital pilots, far fewer manage to scale them into enterprise‐wide transformation. Drawing on 26 semi‐structured interviews conducted within Roche, a global pharmaceutical company, we examine how two AI‐enabled initiatives, AI‐driven translation and robotic process automation for regulatory tasks, were scaled across complex regulatory environments. The findings identify three organisational development areas required for scalable digital transformation: building a mindset and capacity for scaling pilots, embedding standardisation and integration and managing information flows under regulatory complexity. We further identify two mechanisms that enable these development areas to translate into scalable outcomes: impact assessment as a stage‐gate discipline and visioning around information flows. From this analysis, we distil five lessons for practice: (1) treat pilots as stepping stones rather than isolated experiments; (2) design digital pilots for reusability and interoperability; (3) embed regulatory adaptability into pilot design; (4) use impact assessment to govern scale‐up decisions and (5) anchor digital initiatives in a shared vision of information flows. These findings offer practical guidance for organisations seeking to scale digital transformation while maintaining coherence, compliance and enterprise‐wide impact in highly regulated industries.