Global Regulatory Submission Manager

Ferring Pharmaceuticals

Kastrup, Denmark
Global regulatory submissions coordination
Ectd and electronic dossier publishing
Regulatory documentation management
As a Global Submission Manager, you will coordinate and execute global regulatory submissions across multiple regions and time zones, managing the full submission lifecycle from planning to dossier publishing

Job Summary

  • As a Global Submission Manager, you will coordinate and execute global regulatory submissions across multiple regions and time zones, managing the full submission lifecycle from planning to dossier publishing.
  • You will join a small, dedicated Global Submission Management team responsible for electronic regulatory submissions across various regions including EU, CA, AU, and EAEU, collaborating closely with Regulatory Affairs globally.
  • Ferring Pharmaceuticals offers an international, dynamic, and collaborative environment with 600 highly skilled colleagues at their International Pharma Science Center in Denmark, providing a state-of-the-art workplace with easy access to Copenhagen Airport.

Matching Summary

As a Global Submission Manager, you will coordinate and execute global regulatory submissions across multiple regions and time zones, managing the full submission lifecycle from planning to dossier publishing.

Skills & Requirements

Must-have

  • Global regulatory submissions coordination
  • eCTD and electronic dossier publishing
  • Regulatory documentation management
  • Cross-functional collaboration
  • Regulatory submission lifecycle knowledge
  • Publishing system experience (Lorenz preferred)
  • Document management system experience (Veeva preferred)

Nice-to-have

  • Continuous process optimization
  • Training and mentoring global colleagues
  • Excellent communication skills
  • Ability to work under tight deadlines
  • Technical flair and IT systems understanding
  • Experience working in fast-paced environments

Key Requirements

  • Hands-on experience with Lorenz publishing system
  • Experience with Veeva document management system
  • Knowledge of eCTD requirements and electronic submissions
  • Proven Regulatory Affairs experience
  • Relevant master’s degree or equivalent work experience
  • Located in the Øresund region

Work Rights

Must be located in the Øresund region

Tailored Resume

Cover Letter