Silvana Huemer

Silvana Huemer is an experienced professional in the field of regulatory affairs, currently serving as Associate Director of Global Regulatory Affairs Development Strategy at Alexion Pharmaceuticals, Inc. since November 2022, while also holding the position of Senior Regulatory Affairs Specialist at Alexion Pharma Canada since May 2016. Silvana has expertise in Biological New Drug Submissions, post-approval CMC and clinical submissions, and has authored key regulatory documentation such as Product Monographs and Clinical Assessment Packages. Additionally, Silvana has a background as a Manager of Regulatory Affairs and as an instructor for the Regulatory Affairs II course at Seneca College. Prior experience includes working as a Territory Manager at Merck Frosst Canada, establishing relationships within the medical community. Silvana holds a Bachelor of Science, Honours, in Biology from the University of Toronto and has completed further education at Seneca Polytechnic.