Karen Long holds four Regulatory Affairs Certificates (RAC): General Scope, Canadian, European and US RAC. She also holds a Master of Science degree in Pharmaceutical Sciences and a Bachelor of Science degree in Chemistry.
Karen entered Regulatory Affairs with positions at QLT and Inex Pharmaceutical. Currently, Karen is the Senior RA Specialist at Angiotech Pharmaceuticals Inc. Karen’s expertise is with combination products/devices; preparation of: technical files; CMC reports for US, EU, and Canadian submissions; clinical study reports; 510(k)s; annual reports; FDA correspondence; and regulatory training materials. Prior to her over 16 years of RA experience Karen worked as a Stability Chemist at Stanley Pharmaceuticals and Teaching and Research Assistant for the Chemistry Department at UBC.
Karen has been on the Executive Steering Committee of the BC Regulatory Affairs Professional Society since 2007.