Senior Regulatory Submission Manager

Cslbehring Com Tr

Global regulatory submissions
Ectd, nees, and paper formats
Electronic document management systems
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
  • electronic document management systems
  • ICH guidelines
  • health authority requirements

Nice-to-have

  • advancing regulatory excellence
  • meaningful work
  • 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 EU, US, Canada, Switzerland, Australia requirements
  • Familiarity with Veeva RIM Suite
  • Experience managing outsourced publishing vendors

Work Rights

Not specified

Tailored Resume

Cover Letter