The Regional Dossier Publisher is responsible for publishing key regulatory submissions in the region and supporting the publishing work carried out by the regional publishing team
Job Summary
The Regional Dossier Publisher is responsible for publishing key regulatory submissions in the region and supporting the publishing work carried out by the regional publishing team.
The RDP will be the regional expert for regulatory submission capabilities, including dossier structures and file formats, electronic submissions, and transmission.
The company offers an exciting work in a great team, global projects, an international environment, and a hybrid working model with flexible role patterns.
Matching Summary
The Regional Dossier Publisher is responsible for publishing key regulatory submissions in the region and supporting the publishing work carried out by the regional publishing team.
Skills & Requirements
Must-have
Regulatory submission capabilities expert
Dossier format requirements identification
Electronic submissions and transmission
Publishing processes and tools
Regional expert for EU and EEMEA
Nice-to-have
Advocating for standardization
Technical impact assessments
Mentor/Coach external publishers
Improvement process and tools projects
Key Requirements
Minimum 3 years publishing experience
Knowledge in Ennov Insight Publisher and/or Lorenz Docubridge
Working knowledge of standard computer applications
Knowledge of publishing requirements in EU and EEMEA regions