Karolyn Gale Emergent BioSolutions

Karolyn Gale, BSc, Hons., RAQC, is a Vice President, Regulatory Affairs at Emergent BioSolutions Inc. With more than 20 years of pharmaceutical experience, she has in-depth chemistry and manufacturing/clinical/regulatory knowledge in pharmaceutical drug development and license maintenance in a wide range of therapeutic areas for both prescription pharmaceuticals and biologics. In her current role she and her team are responsible for the global RA activities related to the Regulatory Affairs aspects of Change Management, CMC/Compliance and regulatory support of CDMO activities. In addition, she has a proven track record in preparing, submitting and negotiating new drug and biologic license approvals, other marketing authorizations, and post approval changes with both Health Canada and the Food and Drug Administration. She has been an active member of the PDAs Post-Approval Changes for Innovation in Availability of Medicines (PAC iAM) Task Force, including co-chair and co-author for an upcoming technical report on post approval change and leading a team to provide comments on the draft ICHQ12 document. Karolyn holds a BSc. from McMaster University and a post-graduate certificate in Regulatory Affairs and Quality Operations from Seneca College.