Gra Cmc Global Pmf Lead

Hearthstone Sl

Regulatory product strategy development
Compliance with fda, eu, ca, au regulations
Leadership of regulatory teams
CSL Behring is a global biotherapeutics leader focused on innovative therapies to address unmet medical needs in immunology, hematology, cardiovascular, metabolic, respiratory, and transplant areas

Job Summary

  • CSL Behring is a global biotherapeutics leader focused on innovative therapies to address unmet medical needs in immunology, hematology, cardiovascular, metabolic, respiratory, and transplant areas.
  • The role involves establishing team priorities, coordinating intracompany activities, and interfacing with regulatory bodies worldwide to ensure product registration and compliance.
  • CSL fosters a culture of inclusion and belonging, emphasizing diversity, empathy, and innovation to better serve patients and sustain a diverse workforce.

Matching Summary

CSL Behring is a global biotherapeutics leader focused on innovative therapies to address unmet medical needs in immunology, hematology, cardiovascular, metabolic, respiratory, and transplant areas.

Skills & Requirements

Must-have

  • Regulatory product strategy development
  • Compliance with FDA, EU, CA, AU regulations
  • Leadership of regulatory teams
  • Product registration and licensure
  • Biologics regulatory experience

Nice-to-have

  • Collaboration across global sites
  • Fostering technology adoption
  • Knowledge sharing and stakeholder engagement

Key Requirements

  • Advanced degree in Life Science or Business
  • 10+ years regulatory experience in pharmaceutical industry
  • 5+ years leadership experience
  • Biologics regulatory experience preferred

Work Rights

Not specified

Tailored Resume

Cover Letter