Senior Regulatory Submission Manager

CSL Behring

Unknown
Global regulatory submission management
Regulatory publishing and compliance
Cross-functional team coordination
We are seeking a Senior Regulatory Submission Manager to contribute to the delivery of high‑quality, timely global regulatory submissions supporting our investigational and marketed products

Job Summary

  • We are seeking a Senior Regulatory Submission Manager to contribute to the delivery of high‑quality, timely global regulatory submissions supporting our investigational and marketed products.
  • CSL Behring is a global biotherapeutics leader driven by our promise to save lives and focused on serving patients’ needs by using the latest technologies.
  • At CSL, Inclusion and Belonging is at the core of our mission and who we are, fueling innovation and fostering a diverse workforce.

Matching Summary

We are seeking a Senior Regulatory Submission Manager to contribute to the delivery of high‑quality, timely global regulatory submissions supporting our investigational and marketed products.

Skills & Requirements

Must-have

  • global regulatory submission management
  • regulatory publishing and compliance
  • cross-functional team coordination
  • electronic document management systems
  • outsourced publishing vendor management

Nice-to-have

  • strong organisational skills
  • attention to detail
  • matrixed global environment navigation
  • global collaboration
  • regulatory excellence focus

Key Requirements

  • Bachelor’s degree in Life Sciences or related discipline
  • 5+ years pharmaceutical regulatory experience
  • experience preparing dossiers for international markets
  • knowledge of EU, US, Canada, Switzerland, Australia health authority requirements
  • familiarity with ICH guidelines
  • experience with Veeva RIM Suite
  • experience managing outsourced publishing vendors

Work Rights

Not specified

Tailored Resume

Cover Letter