Gra Cmc Specialist

CSL

Multiple Locations
Global regulatory cmc strategy
Regulatory submissions management
Cross-functional collaboration
The Team Lead, Global Regulatory Affairs CMC is responsible for partnering closely with CSL’s R&D, Manufacturing, Quality, and Regulatory Affairs stakeholders to deliver innovative and timely regulatory solutions

Job Summary

  • The Team Lead, Global Regulatory Affairs CMC is responsible for partnering closely with CSL’s R&D, Manufacturing, Quality, and Regulatory Affairs stakeholders to deliver innovative and timely regulatory solutions.
  • This role promotes strong cross-functional collaboration and effective communication across Global Operations, R&D, Global Regulatory Affairs, and other CSL business functions to support strategic business objectives.
  • CSL Behring is a global biotherapeutics leader focused on discovering, developing, and delivering innovative therapies using advanced scientific platforms to address unmet medical needs.

Matching Summary

The Team Lead, Global Regulatory Affairs CMC is responsible for partnering closely with CSL’s R&D, Manufacturing, Quality, and Regulatory Affairs stakeholders to deliver innovative and timely regulatory solutions.

Skills & Requirements

Must-have

  • Global regulatory CMC strategy
  • Regulatory submissions management
  • Cross-functional collaboration
  • Regulatory compliance and lifecycle management
  • Interaction with regulatory agencies
  • Change control assessments

Nice-to-have

  • Mentoring and team leadership
  • Effective communication skills
  • Problem solving and contingency planning
  • Global regulatory policy development
  • Stakeholder engagement
  • Adaptability and resilience

Key Requirements

  • Bachelor’s degree in biological or chemical sciences
  • Advanced degree preferred (MS, PhD)
  • Over 5 years progressive regulatory experience
  • Experience in biologics or plasma industry
  • In-depth knowledge of global drug regulations
  • Proven expertise in regulatory submissions
  • Strong leadership and mentoring skills

Work Rights

Not specified

Tailored Resume

Cover Letter