Regulatory Submission Manager

CSL SEQIRUS

Not specified
Global regulatory submissions
Ectd, nees, and paper formats
Cross-functional team collaboration
CSL Seqirus is looking for a Regulatory Submission Manager to coordinate global regulatory submission activities for their investigational and marketed products. The ideal candidate will have significant experience in pharmaceutical regulatory environments, particularly in submission management and publishing

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

Match Score: 85

CSL Seqirus is looking for a Regulatory Submission Manager to coordinate global regulatory submission activities for their investigational and marketed products. The ideal candidate will have significant experience in pharmaceutical regulatory environments, particularly in submission management and publishing.

Skills & Requirements

Must-have

  • Global regulatory submissions
  • eCTD, NEES, and paper formats
  • Cross-functional team collaboration
  • Vendor oversight and performance monitoring
  • Health authority requirements
  • ICH guidelines

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
  • Familiarity with Veeva RIM Suite
  • Experience managing outsourced publishing vendors

Work Rights

Not specified

Tailored Resume

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