Regulatory Affairs - Regional Dossier Publisher

539

Central Bohemian, Czech Republic
Hybrid
Regional dossier publisher expertise
Regulatory submission capabilities
Dossier structure and file formats
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 opportunity to learn and grow professionally within the company globally, a hybrid working model, and a competitive salary with incentive pay.

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 Publisher expertise
  • Regulatory submission capabilities
  • Dossier structure and file formats
  • Electronic submissions and transmission
  • Ennov Insight Publisher or Lorenz Docubridge
  • EU and EEMEA publishing requirements

Nice-to-have

  • Advocating for standardization
  • Technical impact assessments
  • Mentor/Coach external publishers
  • Global projects and international environment
  • Continuous improvement and tools projects

Key Requirements

  • Minimum 3 years publishing experience
  • Knowledge of publishing tools
  • Working knowledge of standard computer applications
  • Knowledge of Document Management systems
  • Knowledge of regulatory registration procedures

Work Rights

Not specified

Tailored Resume

Cover Letter