Gra Cmc Specialist

CSL Behring

Global regulatory cmc strategy
Cmc regulatory submissions
Change control assessments
The Team Lead, Global Regulatory Affairs CMC is responsible for defining global regulatory strategies, objectives, and policies that advance and support the development, registration, and lifecycle management of CSL’s biological & non-biol. products

Job Summary

  • The Team Lead, Global Regulatory Affairs CMC is responsible for defining global regulatory strategies, objectives, and policies that advance and support the development, registration, and lifecycle management of CSL’s biological & non-biol. products.
  • This role promotes strong cross-functional collaboration and effective communication across Global Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to drive alignment and support CSL’s strategic business objectives.
  • 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

The Team Lead, Global Regulatory Affairs CMC is responsible for defining global regulatory strategies, objectives, and policies that advance and support the development, registration, and lifecycle management of CSL’s biological & non-biol. products.

Skills & Requirements

Must-have

  • Global Regulatory CMC Strategy
  • CMC regulatory submissions
  • Change control assessments
  • Interaction with regulatory agencies
  • Cross-functional collaboration

Nice-to-have

  • Innovative regulatory approaches
  • Strong positive relationships with regulators
  • Operational excellence
  • Inclusion and Belonging

Key Requirements

  • Bachelor's degree in biological or chemical sciences
  • Over 5 years of progressive experience in regulatory roles
  • In-depth knowledge of global regulations
  • Proven expertise in authoring, reviewing, and managing regulatory submissions
  • Ability to lead cross-functional teams

Work Rights

Not specified

Tailored Resume

Cover Letter