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Kristen Sauter is an accomplished professional in regulatory affairs and information management, currently serving as Senior Director and Head of Global Regulatory Affairs Information Management & Digital Innovation at Takeda since November 2019. With extensive experience across various roles, Kristen has held senior positions at CGI, Paragon, and Navitas Life Sciences, as well as founding LifeSciHub, LLC. Kristen has demonstrated a strong ability to deliver strategic regulatory consulting services, optimize processes, and lead teams through complex projects. Educational qualifications include an MBA from Suffolk University, a Graduate Certificate in Regulatory Affairs from Northeastern University, and a BS in Biology from Westfield State University.