Manager, Regulatory Clinical Trial Authorization (cta)

CSL Ltd

5 years managing clinical trial authorizations
Eu ctr regulatory requirements knowledge
Oversight of external vendors and cros
The role is responsible for translating global CTA strategies into study-specific regulatory approaches while ensuring alignment with development priorities

Job Summary

  • The role is responsible for translating global CTA strategies into study-specific regulatory approaches while ensuring alignment with development priorities.
  • Candidates must act as the primary oversight contact for external partners, monitoring vendor performance against agreed KPIs and quality expectations.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies in immunology, hematology, and other areas.

Matching Summary

The role is responsible for translating global CTA strategies into study-specific regulatory approaches while ensuring alignment with development priorities.

Skills & Requirements

Must-have

  • 5 years managing Clinical Trial Authorizations
  • EU CTR regulatory requirements knowledge
  • Oversight of external vendors and CROs
  • ICH guidelines and GCP compliance expertise
  • Risk-based CTA planning and execution

Nice-to-have

  • Strong problem-solving and judgment skills
  • Experience with inspection readiness preparation
  • Ability to drive process improvements
  • Excellent written and oral communication
  • Matrix environment management experience

Key Requirements

  • Minimum 5 years experience in managing CTAs
  • Degree in life science, pharmacy, or health field
  • Extensive knowledge of ICH guidelines and GCP
  • Proven experience overseeing external vendors/CROs

Work Rights

Not specified

Tailored Resume

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