Senior CMC Regulatory Affairs Manager
$150k - $180k par annéeAbCellera
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
L'offre d'emploi a été publiée Il y a un mois
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