Denyse Baker is senior director and team lead for global regulatory policy with AstraZeneca. As a member of the Policy, Intelligence and Regional Strategy team she focuses on fostering collaboration and transparent communication on cross industry advocacy initiatives which follow the science and achieve positives outcomes for patients. Previously Denyse held leadership roles in regulatory affairs, manufacturing operations and engineering with Eli Lilly, led the implementation of quality systems at FDA/CDER, and was director of science and regulatory affairs for PDA. Denyse is currently vice chair of PDA’s Regulatory and Quality Advisory Board, co-leader of the Quality Management Maturity Task Force, and member of the Quality Culture Assessment ANSI Standard Working Group. She is also a member of the FDA Alumni Association Board of Directors. Denyse holds a B.S in Mechanical Engineering from Northwestern University, is a licensed professional engineer and maintains RAC certifications in US and EU regulatory affairs.