Associate Director, Regulatory Affairs
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
8+ ansCandidates need 8 to 10 years of regulatory affairs experience in biotech or pharma, ideally with biologics, plus experience with FDA, EMA and Health Canada submissions. They also need strong analytical, cross-functional, communication and organizational skills.
Regulatory affairs, Project management, Pharmaceutical industry, Regulatory compliance, Interpersonal skills, Organizational skills
Gestionnaire principal(e), Affaires réglementaires CMC
Montréal, QCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
8+ ansConnaissance approfondie des exigences CMC et de la structure eCTD; Expérience de rédaction du module 3 pour produits biologiques et combinés; Maîtrise de la réglementation de Santé Canada, de la FDA et de l'EMA
eCTD
Director, CMC Quality
Vancouver, BCAbCellera: AbCellera is a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology,…
12+ ansCandidates need a life sciences or engineering bachelor's degree, with an MS or PhD preferred, and 12+ years in biopharmaceutical quality, regulatory or manufacturing compliance. Strong global cGMP knowledge, control and comparability strategy expertise, and proven leadership are required.
Leadership, Regulatory compliance, Supply chain management, Good manufacturing practices, Inspection, Chemical engineering