The role ensures that Clinical Trial Authorization activities are planned, governed, and overseen in line with CSL regulatory expectations and quality standards
Job Summary
The role ensures that Clinical Trial Authorization activities are planned, governed, and overseen in line with CSL regulatory expectations and quality standards.
Candidates will act as the primary oversight contact for external partners performing CTA activities while monitoring vendor performance against agreed KPIs.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies in immunology, hematology, and other therapeutic areas.
Matching Summary
The role ensures that Clinical Trial Authorization activities are planned, governed, and overseen in line with CSL regulatory expectations and quality standards.
Skills & Requirements
Must-have
5+ years managing Clinical Trial Authorizations
Experience with EU CTR requirements
Oversight of external vendors and CROs
Knowledge of ICH guidelines and GCP
Risk-based regulatory planning
Nice-to-have
Strong problem-solving judgment
Excellent written and oral communication
Continuous process improvement mindset
Inspection readiness experience
Matrix environment management skills
Key Requirements
Minimum 5 years experience in managing CTAs
Degree in life science, pharmacy, or health/medical field