Bonnie has over 30 years of regulatory experience in the pharmaceutical industry including Canada, U.S. and International.
She has extensive experience with clinical applications (INDs, CTAs) and innovative biologic and pharmaceutical registrations covering CNS, virology, immunology, oncology, CV, GI/metabolism, ophthalmology, blood products, and rare genetic diseases, and has filed over 50 INDs/CTAs and completed over 25 new drug (branded) registrations / launches. She has also led medical information, pharmacovigilance, and R&D Compliance teams. Bonnie’s experience spans large and small biotech and pharmaceutical companies, including Shire (15 years) where she led the company’s Canadian regulatory team, and BioChem Pharma (which became Canada’s largest Biotech company; merged with Shire in a C$13 billion merger in 2000) where she was the head of regulatory as well as R&D compliance. Prior to BioChem Pharma, Bonnie was at Novartis / Sandoz (10 years) where she led several European and international regulatory projects. While at Shire (until 2017 prior to joining Fortuna), Bonnie was also an active member of the Canadian business leadership team and Shire’s International Regulatory leadership team.