Senior CMC Regulatory Affairs Manager

AbCellera seeks a Senior CMC Regulatory Affairs Manager to develop and execute global regulatory strategies for biologics programs across development stages. The role involves leading submissions, coordinating with cross-functional teams, and ensuring compliance with international health authority requirements.

Responsibilities

• Lead planning, authoring, and execution of global CMC regulatory submissions and briefing documents
• Develop and manage responses to health authority queries and regulatory feedback
• Provide strategic CMC guidance and review technical documentation for regulatory compliance
• Manage CMC regulatory timelines and coordinate with Manufacturing, Quality, and Analytical Development teams
• Monitor regulatory environment, assess program risks, and establish mitigation strategies

Requirements

• Deep understanding of CMC regulatory requirements and eCTD structure for biologics
• Experience authoring Module 3 content for INDs, IMPDs, BLAs, NDAs, and NDSs
• Knowledge of FDA, Health Canada, and EMA regulations for biologics and combination products
• 8+ years of relevant regulatory affairs or CMC strategy experience
• Advanced degree or bachelor's degree in biological, pharmaceutical, chemical, or engineering sciences
• Strong technical writing and oral communication skills
• Ability to manage multiple priorities in fast-paced environments

Compensation: CAD $150,000 - $180,000 annually, plus equity, annual bonus, and 6% RRSP contribution