Senior CMC Regulatory Affairs Manager

AbCellera seeks a Senior CMC Regulatory Affairs Manager in Montreal to lead global regulatory strategy and submissions for biologics programs from preclinical through commercialization. The role requires deep expertise in CMC documentation, health authority interactions, and cross-functional collaboration with manufacturing and quality teams.

Responsibilities

• Lead planning, authoring, and execution of global CMC regulatory submissions including INDs, IMPDs, and BLAs/NDAs
• Provide strategic CMC regulatory guidance and critical review of technical documentation to ensure compliance
• Manage CMC regulatory timelines and deliverables in partnership with Manufacturing, Quality, and Analytical Development
• Identify regulatory risks, assess program impact, and establish mitigation strategies
• Support cross-functional project teams to innovate strategies and accelerate submission timelines

Requirements

• Deep understanding of CMC regulatory requirements, eCTD structure, and Module 3 preparation for biologics
• Experience developing CMC strategies and submissions for biologics, combination products, and drug-device delivery systems
• Thorough knowledge of Health Canada, FDA, and EMA regulations for biologics
• Skilled regulatory professional and technical writer with strong oral communication abilities
• Bachelor's degree in biological, pharmaceutical, chemical, or engineering sciences plus 8 years relevant experience
• Detail-oriented, highly organized, capable of managing multiple priorities in fast-paced environments