Regional Submission Publishing Senior Specialist
Core
Execute day-to-day publishing activities for priority and lifecycle submissions, delivering high-quality, agency-compliant regulatory dossiers across the APAC region.
Role type
Senior individual contributor regulatory submission publishing specialist
Builds
Electronic regulatory dossiers for regional agencies
Domain
Pharmaceutical regulatory affairs and submission publishing
Required skills
Regulatory submission publishing, Electronic dossier preparation, Agency gateway transmission, Publishing systems (Liquent/Lorenz/RIIM), Cross-functional collaboration, Continuous improvement, Quality compliance, Technical training
Preferred skills
Biotechnology, Pharmacovigilance, Project management, Process improvements
Technologies
Liquent Insight Publisher, Lorenz DocuBridge, RIIM systems
Responsibilities
Execute daily publishing activities for priority submissions, Contribute to continuous improvement of publishing workflows, Provide hands-on technical support and training on dossier structures, Support publishing system changes and validation, Maintain accurate operational records, Monitor regulatory updates and industry practices
Seniority
Senior, hands-on IC