Carolyn Hosannah, M.S., RAC, Director, Regulatory Affairs

Carolyn Hosannah, MS, RAC, has over 17 years of experience providing regulatory affairs support in various therapeutic areas worldwide.  As part of various global project teams, she has provided regulatory guidance for the development of drug and biologic products in Phase I through Phase III of development as well as post-marketing.

Carolyn provides clients with strategic and operational regulatory expertise and the leadership necessary to advance product development.  She has invaluable experience in preparing regulatory dossiers in CTD/eCTD format for clinical trials, marketing applications, amendments, and supplements for various prescription and over-the-counter products.  She has expertise in writing and reviewing regulatory strategies, as well as preparing clinical and CMC documents to meet established submission requirements.  She also acts as a liaison with FDA and Health Canada officials to coordinate submissions, address issues, facilitate pre-meeting preparations, and prepare responses to agency questions to meet tight timelines.  Carolyn also has expertise in requirements for marketing cosmetics in Canada and the US.  Carolyn has many years of pharmacovigilance experience establishing procedures for safety reporting in clinical trials to post marketing reports, which includes preparation and review of periodic safety update reports and serious adverse event reporting in Canada and the US.  

She currently leads the Regulatory Affairs and Electronic Submission Publishing departments in the Pharmaceuticals & Healthcare Group at Intertek.