Regulatory Affairs - Regional Dossier Publisher

Merck & Co., Inc.

Competitive salary; incentive pyy included; pensio...
Hybrid
3 years publishing experience
Ennov insight publisher or lorenz docubridge knowledge
Eu and eemea regulatory dossier requirements
The Regional Dossier Publisher is responsible for publishing key regulatory submissions in the EU and EEMEA regions while supporting regional teams

Job Summary

  • The Regional Dossier Publisher is responsible for publishing key regulatory submissions in the EU and EEMEA regions while supporting regional teams.
  • This role serves as a technical expert for local Country RA teams, providing training on publishing processes and acting as a point of contact for health authorities.
  • The company offers a hybrid working model, competitive salary, incentive pay, and extensive benefits including 5 weeks of annual leave and tax-free cafeteria options.

Matching Summary

The Regional Dossier Publisher is responsible for publishing key regulatory submissions in the EU and EEMEA regions while supporting regional teams.

Salary

Competitive salary; Incentive pay included; Pension and health insurance contributions

Skills & Requirements

Must-have

  • 3 years publishing experience
  • Ennov Insight Publisher or Lorenz Docubridge knowledge
  • EU and EEMEA regulatory dossier requirements
  • Electronic submission transmission capabilities
  • MS Office, Adobe Acrobat, and Document Management systems

Nice-to-have

  • Knowledge of regulatory registration procedures in EU/EEMEA
  • Strong analytical and customer service skills
  • Ability to work under tight deadlines
  • Experience mentoring external publishers
  • Participation in improvement process projects

Key Requirements

  • Minimum 3 years of publishing experience
  • Working knowledge of Ennov Insight Publisher or Lorenz Docubridge
  • Demonstrated ability to meet critical submission targets

Work Rights

Not specified

Tailored Resume

Cover Letter