Course taught

  • PHRMRA 536 Skills for the Regulatory Affairs Professional

Biography

Brent Lewis is an affiliate assistant professor in the Department of Pharmacy. He began his career in biotechnology, establishing and overseeing the quality control labs for biotechnology products where he wrote the chemistry, manufacturing and control (CMC) sections of several investigational new drug (IND) applications. Lewis went on to become a vice president of quality and regulatory affairs at several global medical device companies where he managed complex 510k submissions; led routine and for-cause FDA inspections; resolved FDA warning letters; oversaw mergers, acquisitions and integrations; and established quality systems for various companies. Today, as an IT leader responsible for quality, regulatory, R&D and commercial IT solutions at a global medical device company, he’s at the intersection of quality, regulatory and business operations, and focused on solutions to harmonize them. He has a bachelor’s degree in biology from Seattle University.