Regulatory Affairs - Regional Dossier Publisher
Core
Regional subject matter expert for regulatory submission publishing, managing dossier structures, file formats, and electronic transmissions to health authorities in EU and EEMEA.
Role type
Senior Regulatory Dossier Publisher (Regional)
Builds
Regulatory submission dossiers and electronic transmissions for health authorities
Domain
Pharmaceutical Regulatory Affairs (EU/EEMEA)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission publishing, Dossier assembly, Electronic submission formats, Transmission gateways, Document Management Systems, MS Office, Adobe Acrobat, MS Project, Technical impact assessment, Process validation, External resource management
Preferred skills
EU and EEMEA regulatory registration procedures, System testing, Performance measurement
Technologies
Ennov Insight Publisher, Lorenz Docubridge, Document Management Systems
Responsibilities
Maintain and apply dossier format requirements for regulatory submissions, Support country Regulatory Affairs teams with local publishing needs, Collaborate with central publishing teams to execute regional processes, Lead technical impact assessments for submission requirements, Provide technical guidance and training to country teams, Act as technical point of contact for health authorities, Mentor and manage external publishing resources
Seniority
Senior, hands-on IC with regional oversight