Senior Regulatory Submission Manager

Cslbehring Com Au

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
  • Health authority requirements (EU, US, Canada, Switzerland, Australia)
  • ICH guidelines

Nice-to-have

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

Key Requirements

  • Bachelor's degree in Life Sciences, Pharmacy, or related discipline
  • 5+ years pharmaceutical regulatory experience
  • Experience preparing dossiers for core and international markets
  • Familiarity with Veeva RIM Suite
  • Experience partnering with or managing outsourced publishing vendors

Work Rights

Not specified

Tailored Resume

Cover Letter