Global Regulatory Submissions Lead — eCTD & Publishing

AbCellera

Vancouver

On-site

CAD 93,000 - 116,000

Full time

6 days ago

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Benefits offered by this job

Equity

Annual bonus

RRSP contribution

Active lifestyle allowance

Health benefits

Professional development

Job summary

AbCellera is seeking a meticulous Regulatory Submissions Specialist to lead electronic publishing of clinical development submissions. You will format, compile, and ensure compliance across global health authorities, coordinating with internal stakeholders to meet tight timelines.

You’ll apply 5+ years in regulatory operations, a Bachelor’s degree, and strong experience with eCTD, Veeva RIM, submission gateways, and regulatory processes to ensure high-quality submissions and seamless lifecycle

Qualifications

5+ years experience in regulatory operations or equivalent.
Bachelor's degree required; equivalents considered.
Experience with eCTD publishing (CTAs, INDs, BLAs/NDAs).
Extensive experience with Veeva RIM and submission portals.
Strong understanding of Regulatory Affairs processes and submission lifecycle.
Highly organized with a methodical approach and attention to detail.

Responsibilities

Compile, publish, and validate regulatory submissions per health authority requirements.
Support regulatory submissions across US, Canada, Australia, EU, and other regions.
Ensure accuracy and technical compliance of published submissions.
Coordinate publishing projects with internal stakeholders and timelines.
Perform quality checks and address validation findings before submission.
Maintain submission documentation and version control.