Regional Submission Publishing Senior Specialist
Core
Execute day-to-day publishing activities for regulatory dossiers across the APAC region, ensuring timely, accurate, and agency-compliant preparation, transmission, and archiving.
Role type
Senior individual contributor regulatory submission publishing specialist
Builds
Agency-compliant regulatory dossiers for pharmaceutical/biotech submissions
Domain
Pharmaceutical regulatory affairs / Submission publishing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission publishing, Electronic dossier preparation, Agency gateway transmission, Publishing systems (Liquent/Lorenz/RIIM), Cross-functional collaboration, Continuous improvement, Risk escalation, Documentation management
Preferred skills
None stated
Technologies
Liquent Insight Publisher, Lorenz DocuBridge, GRACS RIIM
Responsibilities
Execute daily publishing activities for priority and lifecycle submissions, Contribute to continuous improvement of publishing workflows and documentation, Provide hands-on technical support and training on dossier structures and tools, Support complex multi-market submissions under guidance, Maintain accurate operational records and status updates, Monitor regulatory updates and apply knowledge to daily activities
Seniority
Senior, hands-on IC
