The role involves defining global regulatory strategies to support the development and lifecycle management of CSL's biological and non-biological product portfolios
Job Summary
The role involves defining global regulatory strategies to support the development and lifecycle management of CSL's biological and non-biological product portfolios.
Candidates will act as an authorized official representing CSL in interactions with regulatory agencies and ensuring timely responses to inquiries.
This hybrid position requires onsite work three days a week within the Holly Springs, Broadmeadows, or Liverpool offices.
Matching Summary
The role involves defining global regulatory strategies to support the development and lifecycle management of CSL's biological and non-biological product portfolios.
Skills & Requirements
Must-have
Global regulatory CMC strategy leadership
Biologics and plasma industry experience
Regulatory submission authoring and management
Change control assessment expertise
Cross-functional stakeholder collaboration
Nice-to-have
Advanced degree in biological or chemical sciences
Innovative regulatory approach implementation
Strong relationship building with health authorities
Strategic problem solving and contingency planning
Key Requirements
Bachelor's degree required; MS/PhD preferred
Over 5 years progressive regulatory experience in biologics/plasma
Deep knowledge of global drug regulations and standards