Senior Regulatory Submission Manager

CSL Behring

Global regulatory submissions
Ectd, nees, and paper formats
Cross-functional team coordination
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 regulatory submission activities across multiple regions, partnering closely with cross-functional teams and external vendors.
  • Ensure compliance with global regulatory publishing and submission standards, while monitoring evolving international requirements.

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 coordination
  • vendor oversight and performance monitoring
  • compliance with global standards

Nice-to-have

  • advancing regulatory excellence
  • meaningful work and 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 health authority requirements
  • Familiarity with Veeva RIM Suite
  • Experience partnering with or managing outsourced publishing vendors

Work Rights

Not specified

Tailored Resume

Cover Letter