Regulatory Affairs Compliance Specialist
$93k - $116k per yearAbCellera
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.
Responsibilities
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
Requirements
- 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
Compensation: CAD $93,000 - $116,000 annually, plus equity, performance bonus, and 6% RRSP contribution
Vacancy posted a month ago
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