As Director, Regulatory Policy and Intelligence, Colleen advises clients on regulatory policy matters, helping them to navigate complex regulatory frameworks and to anticipate and respond to policy shifts that may impact drug development in an evolving regulatory landscape.

Colleen has over 27 years of experience at the FDA. Most recently, she served as a Regulatory Policy Advisor in the Office of New Drug Policy in CDER, where she advised on legislative proposals, developed regulations, regulatory policy, and guidance, and advised, as well as advocated for, review staff on regulatory policy matters.

Prior to her work in OND Policy, Colleen served as the Associate Director for Regulatory Affairs in the Office of Drug Evaluation I in CDER, where she provided regulatory advice, guidance, and assistance to management and review staff, as well as leadership and direction through the planning, development, administration, and coordination of regulatory programs and practices.

Colleen started her FDA career at FDA as a Project Manager in the Division of Cardiovascular and Renal Products in the Office of New Drugs where she managed the review of Investigational New Drug applications, New Drug Applications, and other regulatory review projects, as well as provided regulatory advice and support to review staff in their evaluation of these applications.