Regulatory Affairs - Regional Dossier Publisher

med-in.at

Hybrid
Regulatory submission publishing
Dossier assembly and delivery
Electronic submissions and transmission
The Regional Dossier Publisher will be responsible for publishing key regulatory submissions and supporting regional publishing teams to meet submission deadlines

Job Summary

  • The Regional Dossier Publisher will be responsible for publishing key regulatory submissions and supporting regional publishing teams to meet submission deadlines.
  • The role offers exciting work in a global team with opportunities for professional growth, a hybrid working model, and comprehensive benefits including pension, health insurance, and paid leave.
  • The RDP will act as a technical expert and point of contact for regulatory authorities, lead technical impact assessments, and support continuous improvement projects.

Matching Summary

The Regional Dossier Publisher will be responsible for publishing key regulatory submissions and supporting regional publishing teams to meet submission deadlines.

Skills & Requirements

Must-have

  • Regulatory submission publishing
  • Dossier assembly and delivery
  • Electronic submissions and transmission
  • Knowledge of EU and EEMEA regulatory requirements
  • Use of Ennov Insight Publisher or Lorenz Docubridge
  • Process and system maintenance
  • Customer service skills

Nice-to-have

  • Analytical skills
  • Ability to work under tight deadlines
  • Mentoring and coaching external publishers
  • Hybrid working model
  • International environment
  • Standardization advocacy
  • Project participation and system testing

Key Requirements

  • Minimum 3 years publishing experience
  • Knowledge of Ennov Insight Publisher and/or Lorenz Docubridge
  • Working knowledge of MS Office and Document Management systems
  • Knowledge of EU and EEMEA publishing requirements
  • Ability to work under tight deadlines

Work Rights

Not specified

Tailored Resume

Cover Letter