Kristen Sauter
Senior Director, Head, Global RIM, Analytics & Digital Innovation
Takeda Pharmaceuticals
Kristen has 20 years of experience helping life sciences clients create modern and innovative regulatory practices and processes that leverage cutting-edge technology to satisfy both FDA requirements and their bottom line. She has built and led global regulatory operations and project management teams for top industry organizations using forward-facing strategy and business systems. Her experience includes comprehensive knowledge of electronic submissions requirements, connections into e-subs group, strong experience in pharmaceutical process and submission preparation through pre-market and NDA stages of development, and strong exposure and awareness of post-marketing and international filings.