Regulatory Submissions Specialist
AbCellera · Vancouver
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Role summary
AbCellera seeks a Regulatory Submissions Specialist to manage electronic publishing and compilation of clinical development submissions across multiple regulatory regions. The role focuses on ensuring compliance, accuracy, and quality standards for submissions to health authorities including the US, Canada, EU, and Australia.
What they're looking for
- Proven experience with eCTD publishing including CTAs, INDs, BLAs/NDAs
- 5+ years regulatory operations experience or equivalent without degree
- Extensive Veeva RIM system proficiency and submission gateway/portal experience
- Understanding of regulatory affairs processes and submission lifecycle
- Highly organized with methodical, detail-oriented approach
- Strong quality mindset and attention to accuracy
What you'll be doing
- Compile, publish, and validate regulatory submissions per health authority requirements
- Support submissions across US, Canada, Australia, EU, and potential global regions
- Perform quality checks and address validation findings before submission
- Coordinate publishing projects with internal stakeholders and manage timelines
- Maintain submission documentation and version control systems
CompensationCAD $93,000 - $116,000 annually, plus equity, performance bonus, and 6% RRSP contribution
Privacy & handoff
This role links to AbCellera's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.