ROLE
– Oversee DMF compilation & review process activities
– Execute and review eCTD & electronic submissions across regions
– Ensure document version control & governance compliance
– Monitor regulatory intelligence and assess strategic impact
– Drive regulatory & supplement reporting activities
– Coordinate regulatory & health authority management interactions
– Support inspection readiness for DMF and regulatory audits
– Apply risk identification & mitigation across regulatory activities
– Ensure sustained regulatory compliance across product lifecycle
– Support quality & audit readiness initiatives
– PDF processing as per US eCTD specifications
– QC checks of submission components before publishing
– Adherence to SOPs, publishing checklists, and quality standards