Senior Regulatory Submission Manager

Century Center

Melbourne, Australia
Global regulatory submissions
Ectd, nees, and paper formats
Cross-functional team collaboration
Contribute to the delivery of high-quality, timely global regulatory submissions supporting investigational and marketed products

Job Summary

  • Contribute to the delivery of high-quality, timely global regulatory submissions supporting investigational and marketed products.
  • Oversee the preparation, publishing, and submission of global regulatory packages across various application types.
  • CSL Behring is a global biotherapeutics leader driven by our promise to save lives.

Matching Summary

Contribute to the delivery of high-quality, timely global regulatory submissions supporting investigational and marketed products.

Skills & Requirements

Must-have

  • Global regulatory submissions
  • eCTD, NEES, and paper formats
  • Cross-functional team collaboration
  • Vendor oversight and performance
  • Health authority requirements
  • Electronic document management systems

Nice-to-have

  • Advancing regulatory excellence
  • Meaningful work and global collaboration
  • Inclusion and belonging culture

Key Requirements

  • Bachelor’s degree or higher
  • 5+ years pharmaceutical regulatory experience
  • Experience preparing dossiers for core and international markets
  • Working knowledge of ICH guidelines
  • Experience managing outsourced publishing vendors

Work Rights

Not specified

Tailored Resume

Cover Letter