Kristen Sauter, MBA
Sr. Director, Head, Global Regulatory Information Management & Digital Innovation
Takeda Pharmaceutical Company Limited
Kristen Sauter, MBA, is a transformative leader in the life sciences and pharmaceuticals industry, specializing in global regulatory operations and information management. Currently serving as senior director, global head of regulatory info management, analytics, and digital innovation at Takeda, Kristen is responsible for spearheading the integration of legacy data sources, implementing a global platform (Veeva Vault RIM), establishing data analytics, and founding the Global Regulatory Innovation Council.
As the global business lead, Kristen has been globally responsible for the integration of Takeda and Shire's legacy systems and data. Her tenure at CGI, Inc. as R&D practice lead and regulatory domain lead saw her drive strategy and growth in life sciences consulting. Kristen has also been a key figure in regulatory affairs at companies like Navitas, Inc., PPD, Inc., and Vertex Pharmaceuticals. Her expertise is recognized through her involvement in industry forums and many speaking engagements.