Senior Regulatory Submission Manager

Viforpharma

Global regulatory submissions
Ectd, nees, and paper formats
Ich guidelines
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.
  • Oversee the preparation, publishing, and submission of global regulatory packages across various application types.
  • CSL Behring is a global biotherapeutics leader driven by our promise to save lives.

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
  • ICH guidelines
  • electronic document management systems
  • pharmaceutical regulatory experience

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 discipline
  • 5+ years of pharmaceutical regulatory experience
  • Experience preparing dossiers for core and international markets
  • Working knowledge of health authority requirements across EU, US, Canada, Switzerland, and Australia
  • Familiarity with Veeva RIM Suite
  • Experience partnering with or managing outsourced publishing vendors

Work Rights

Not specified

Tailored Resume

Cover Letter