Prepare, format, publish regulatory submission documents in eCTD format.
Compile, review, and QC submission components for accuracy and compliance.
Coordinate submission timelines with Regulatory Affairs teams and stakeholders.
Perform technical validation of submissions using publishing tools.
Submit dossiers to global authorities (FDA, EMA, Health Canada) through gateways.
Maintain submission archives and document management within regulatory systems.

🎯 Requirements

Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or related.
2-5+ years in regulatory publishing or regulatory operations.
Experience with eCTD publishing and submission processes.
Proficiency with Lorenz docuBridge, Extedo eCTDmanager, GlobalSubmit.
Familiarity with Veeva, SharePoint, and other document mgmt systems.
Ability to manage multiple submissions and meet tight deadlines.

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