Regulatory Submission Manager

cslbehring.cl

**
Global regulatory submissions
Submission preparation activities
Ectd, nees, and paper formats
** CSL Behring is seeking a Regulatory Submission Manager to oversee global regulatory submissions for investigational and marketed products. The ideal candidate will have over five years of experience in pharmaceutical regulatory affairs, particularly in submission management, and will thrive in a collaborative environment focused on innovation and patient care. **

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, while overseeing publishing vendors.
  • CSL Behring is a global biotherapeutics leader driven by our promise to save lives, focused on serving patients' needs by using the latest technologies.

Matching Summary

Match Score: 75

** CSL Behring is seeking a Regulatory Submission Manager to oversee global regulatory submissions for investigational and marketed products. The ideal candidate will have over five years of experience in pharmaceutical regulatory affairs, particularly in submission management, and will thrive in a collaborative environment focused on innovation and patient care. **

Skills & Requirements

Must-have

  • global regulatory submissions
  • submission preparation activities
  • eCTD, NEES, and paper formats
  • electronic document management systems
  • publishing vendors oversight

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 health authority requirements
  • Familiarity with Veeva RIM Suite
  • Experience managing outsourced publishing vendors

Work Rights

Not specified

Tailored Resume

Cover Letter