Senior CMC Regulatory Affairs Manager
Montréal, QCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
8+ YOECandidates need deep CMC regulatory knowledge, eCTD and Module 3 authoring experience for biologics and combination products, and a thorough understanding of Health Canada, FDA and EMA rules. A science or engineering degree and about 8 years of relevant experience are expected.
eCTD
Senior CMC Regulatory Affairs Manager
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
8+ YOECandidates need deep knowledge of CMC regulatory requirements, eCTD structure and Module 3 authoring for biologics and combination products. They also need a thorough understanding of Health Canada, FDA and EMA rules, a bachelor's or advanced degree in a science or engineering field, and about 8 years of relevant experience.
Regulatory affairs, Documentation, CTAS, Regulatory compliance