As regulatory teams continue the transition from document-centric to data-centric operations, biopharmas are evaluating their unique regulatory use cases to take advantage of automation and AI. <\/p>\n
\nWhile evolving compliance standards, like IDMP or eCTD 4.0, or the adoption of digital agents can trigger internal alignment on data remediation efforts, organizations like CSL and Alfasigma have elevated these conversations beyond a basic compliance exercise.\n<\/p>\n
\n\u201cWe had to change our perspective and show the real business value that we could create from IDMP. We built a business case beyond compliance that led to organization-wide buy-in, a first-of-its-kind data governance model, and improved traceability,\u201d said Michele Malossi, manager of regulatory digital at Alfasigma.\n<\/p>\n
\nSimilarly, CSL undertook a large-scale data audit to understand each business function\u2019s data domain and use cases. Ultimately, they built a data foundation that illustrates how data flows through the organization, including who produces and consumes it, so teams can make data-driven decisions across R&D.\n<\/p>\n
\nBy embedding intelligent automation into daily workflows, regulatory teams are successfully freeing themselves of administrative, low-value tasks to focus on global submissions.\n<\/p>\n
\nFor mAbxience, implementing standard Veeva RIM configurations allowed them to build advanced AI capabilities including document classification bots, an internal knowledge chatbot, and generative dossier summary tools, which freed the team to focus on complex regulatory tasks and continuous process improvements.\n<\/p>\n
\n\u201cIt\u2019s not about taking jobs from people. It\u2019s to help them with basic tasks, gaining time, and work on more difficult regulatory operations where their knowledge is needed,\u201d said Aur\u00e9lie Bequet, head of regulatory operations at mAbxience.\n<\/p>\n
\nEach organization will execute change management in their own way, but buy-in is a key determinant of success. \u201cYou must win hearts and minds. You must articulate why change is needed, how it will benefit the organization, and what value will be realized from the investment. It\u2019s equally important to get emotional buy-in, which impacts the workforce as a whole. The user community should feel understood and supported during the change,\u201d said Javier Monvoisin, global head of regulatory operations at Sandoz.\n<\/p>\n
\nLong-term business transformation requires ongoing investment from the team to rethink processes. During its Veeva RIM transformation, MSD used functional area collaboration teams to identify necessary capabilities. \u201cWe were able to create sustainable process change and deliver on outcomes faster,\u201d said John Janick, executive director of regulatory innovation and information management at MSD.\n<\/p>\n
\nAdditionally, the company is using AI to evolve its operating model. \u201cHistorically, we\u2019ve looked at processes first, the people in the roles that execute, and then how technology enables them. With the advent of automation and agentic labor, we can look at the technology first to help us in designing a better process,\u201d said Janick.\n<\/p>\n