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 role will assist HQ Colleagues within RPP in the development of the tools and procedures that support our submission publishing procedures.
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
Regional dossier publishing expertise
Electronic submission and transmission knowledge
Dossier format requirements maintenance
Process maintenance for regional requirements
Technical impact assessment of requirements
External publisher mentoring and coaching
Nice-to-have
Advocating for standardization
Customer service and analytical skills
Working with varying educational backgrounds
Key Requirements
Minimum 3 years publishing experience
Knowledge in Ennov Insight Publisher and/or Lorenz Docubridge
Knowledge of publishing requirements in EU and EEMEA regions
Working knowledge of standard computer applications and DMS