Carolyn Hosannah, M.S., RAC, Director, Regulatory Affairs
Carolyn Hosannah, MS, RAC, has over 20 years of experience providing regulatory affairs support in various therapeutic areas. As part of various global project teams, she has provided regulatory guidance for 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, over-the-counter products, combination products, and generic drug 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 U.S. FDA and Health Canada officials to coordinate submissions, address issues, facilitate pre-meeting preparations, and prepare responses to agency questions to meet tight timelines.
She currently leads the Regulatory Affairs and Electronic Submission Publishing departments in the Pharmaceuticals & Healthcare Group at Intertek.
