Roche Shares Regulatory Transformation Journey at Veeva R&D and Quality Summit Connect

More than 4,000 life sciences professionals gathered at this year’s Veeva R&D and Quality Summit Connect to share best practices and see the latest innovations. In the regulatory track, 500+ attendees gained practical knowledge from industry peers at Moderna, Eli Lilly, Seagen, Dermavant, and other leading organizations. Popular topics included harmonizing global regulatory processes, improving user adoption with continuous and agile change management, and getting maximum value from a RIM investment.

Transformation Strategy and Roadmap

The track kicked off with a keynote session on Roche’s regulatory transformation, which is bringing different regulatory functions together under a common set of modern business capabilities to meet present and future patient needs.

Vijay Reddi, who leads a OneRegulatory team, outlined the three strategies for driving regulatory transformation at Roche. They are patient-centricity, real-time insights, and critical enabling, which involves delivering an end-to-end submission process supported by an integrated technology ecosystem. As Vijay elaborated, “We have to make sure we have this strong foundation where we bring all our content, all our data, all our processes, all our technologies and have it fully integrated, rather than in multiple systems that don’t talk to each other.”

Vijay also presented Roche’s high-level transformation roadmap, which lays out key milestones across data, process, content, labeling, and policy. Vijay called Veeva Vault RIM “our backbone in terms of critical enabling,” noting that the platform will connect these activities to realize the OneRegulatory vision. Vijay’s team is taking an agile approach to the long term transformation so they can adapt to changes in technology, business needs, and the regulatory environment.

Engaging With and Across Functions

When discussing what’s required for transformation success, Vijay stressed the importance of taking the business “along the journey.” He recommended working with functional groups from the beginning so it’s clear what future roles and skills are needed. “It’s the individual teams on the frontline—the ones going through the submissions, the approvals, the planning, the authoring—that we need to support,” he said.

Vijay also highlighted the value of cross-functional engagement. Roche’s regulatory transformation has expanded to include other organizations, such as clinical operations, to enable a consistent, holistic approach to working with global health authorities. “Regulatory never submits on its own; it works with other functions,” Vijay explained. “Part of the journey is to remove those silos for greater impact.”

To learn more about Roche’s regulatory transformation, you can view this and all other Summit sessions on demand at Also, be sure to register your interest in next year’s North American R&D and Quality Summit Connect, which will be held in Boston on October 17 – 19, 2022.

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