Regulatory Affairs - Regional Dossier Publisher

leHACK

Competitive salary; incentive pyy mentioned; not s...
Hybrid
3+ years publishing experience
Ennov insight publisher or lorenz docubridge knowledge
Eu and eemea regulatory procedures knowledge
The Regional Dossier Publisher will serve as the regional expert for regulatory submission capabilities, including dossier structures and electronic transmissions

Job Summary

  • The Regional Dossier Publisher will serve as the regional expert for regulatory submission capabilities, including dossier structures and electronic transmissions.
  • This role involves leading technical impact assessments of regional requirements and providing training to Country RA teams on publishing processes.
  • The company offers a hybrid working model, competitive salary, incentive pay, and extensive benefits including 5 weeks annual leave and tax-free cafeteria options.

Matching Summary

The Regional Dossier Publisher will serve as the regional expert for regulatory submission capabilities, including dossier structures and electronic transmissions.

Salary

Competitive salary; Incentive pay mentioned; Not specified

Skills & Requirements

Must-have

  • 3+ years publishing experience
  • Ennov Insight Publisher or Lorenz Docubridge knowledge
  • EU and EEMEA regulatory procedures knowledge

Nice-to-have

  • Strong analytical and customer service skills
  • Ability to work under tight deadlines
  • Experience with MS Project and Document Management systems

Key Requirements

  • Minimum 3 years publishing experience
  • Knowledge of Ennov Insight Publisher
  • Knowledge of EU/EEMEA regulatory registration procedures

Work Rights

Not specified

Tailored Resume

Cover Letter