Regulatory Submissions at 4:00pm – 5:00pm Michael Sauter is a Senior Director of Global Regulatory Operations from Alexion Pharmaceuticals. Most recently Micahel has successfully led and built a new Branded Regulatory Operations team while integrating four recently acquired companies and implementing three major new IT systems, all at the same time. Earlier, Michael Sauter was positioned ar a major pharmaceutical enterprise as a thought leader in the emerging field of Digital Health. Leveraged IT expertise, presentation and negotiation skills, and inspirational leadership to develop effective company-wide Digital Health strategy and innovative tools/business practices. Michael received his B.S., Chemistry. Advanced certificates and training in Data Science, Big Data and Social Analytics, Business Practices, Digital Leadership, Systems Engineering and Structured Analysis and Design, others from Johns Hopkins, MIT, New York University, F. Hoffman-La Roche AG, School of Information Management.