Regulatory Submission Manager

cslbehring.cz

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Global regulatory submissions
Ectd, nees, and paper formats
Cross-functional team collaboration
** CSL Behring is seeking a Regulatory Submission Manager to oversee and coordinate global regulatory submission activities for investigational and marketed products. The ideal candidate should have significant pharmaceutical regulatory experience, particularly in submission management, and a strong understanding of global regulatory requirements. **

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

Match Score: 75

** CSL Behring is seeking a Regulatory Submission Manager to oversee and coordinate global regulatory submission activities for investigational and marketed products. The ideal candidate should have significant pharmaceutical regulatory experience, particularly in submission management, and a strong understanding of global regulatory requirements. **

Skills & Requirements

Must-have

  • global regulatory submissions
  • eCTD, NEES, and paper formats
  • cross-functional team collaboration
  • vendor oversight
  • ICH guidelines

Nice-to-have

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

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter