Kimberley Buytaert-Hoefen

Kimberley Buytaert-Hoefen is the Executive Director & Global Head of Regulatory Affairs at QPS. Kimberley has over 20 years of experience in the Regulatory Affairs field and has worked with clients all over the world on a variety of projects.

Most recently, they were the Director of Regulatory Affairs at Azzur Group, where they were responsible for the direction and coordination of regulatory client consulting the development and implementation of drug discovery and development plans from concept through commercialization.

Before that, Kimberley was the Principal Consultant, Strategic Compliance at PAREXEL where they provided compliance oversight and strategic regulatory consulting services to biopharmaceutical and medical device sponsors.

Kimberley started their career as a Consumer Safety Officer at the FDA. Kimberley has a wealth of experience in both the public and private sector, and their knowledge of the regulatory process is second-to-none.

Kimberley is a highly sought-after speaker and has presented at numerous conferences on topics such as regulatory strategy, clinical development, submissions, and more. Kimberley is also an active member of several professional organizations, including the Regulatory Affairs Professionals Society (RAPS) and the American Association of Pharmaceutical Scientists (AAPS).

Kimberley Buytaert-Hoefen has a Ph.D. in Behavioral Neuroscience from the University of Colorado Boulder and a Bachelor's Degree from Binghamton University.

Some of their coworkers include Karri Nieminen - Senior Director, Sarah Cross - Executive Director & Head of Global Medical Affairs, and Ben Hsu - CAO & GM, QPS LLC. Kimberley Buytaert-Hoefen reports to Ben Chien, Chairman, President & CEO.