Senior CMC Regulatory Affairs Manager

AbCellera · Vancouver

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Role summary

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.

Where this listing comes from

This listing was compiled by RoleLantern from the employer's publicly available posting on Greenhouse, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-04 (originally posted 2026-09-17). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.

What they're looking for

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

What you'll be doing

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

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

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Date posted17 days ago

Last source checkToday

Salary listedNeeds clarity

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