Senior Regulatory Submission Manager

Csmlive

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.
  • Coordinate submission priorities and planning across business units and product portfolios.
  • 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 management
  • health authority requirements

Nice-to-have

  • advancing regulatory excellence
  • meaningful work
  • global collaboration
  • culture of curiosity and empathy

Key Requirements

  • Bachelor’s degree or higher
  • 5+ years pharmaceutical regulatory experience
  • Experience preparing dossiers for core and international markets
  • Working knowledge of EU, US, Canada, Switzerland, and Australia health authority requirements
  • Familiarity with Veeva RIM Suite
  • Experience managing outsourced publishing vendors

Work Rights

Not specified

Tailored Resume

Cover Letter