Donna Wolfington is an accomplished regulatory affairs leader with extensive experience in operational excellence and AI innovation within the pharmaceutical industry. Currently serving as the Executive Director and Head of Operational Excellence in Global Regulatory Operations at Takeda since June 2025, Donna drives enterprise-wide initiatives and designs innovative business processes. Previously, Donna held several leadership positions at Sanofi, including AVP roles overseeing Clinical Documentation and AI Innovation, as well as Global Regulatory Submissions Management, where significant contributions included the implementation of AI technologies and managing a high-volume submissions portfolio. Donna’s career also encompasses impactful roles at Genpact Pharmalink, Shire, Pfizer, GSK, and Merck, focusing on regulatory operations, submissions management, and publishing. Donna holds a BA in Communications from Temple University.
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