Director Regulatory Affairs ANZ
Core
Lead national regulatory operations and strategy for CSL's biotechnology products in Australia and New Zealand, serving as the primary interface with Health Authorities.
Role type
Director, Regulatory Affairs (ANZ)
Builds
Regulatory strategies for new product registrations and lifecycle management for immunology, hematology, cardiovascular, metabolic, respiratory, and transplant therapies.
Domain
Biotechnology / Life Sciences / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic leadership, Health Authority engagement, ANZ regulatory framework expertise, submission management, cross-functional initiative management, compliance monitoring, policy contribution, audit/inspection readiness, CAPA management, stakeholder communication.
Preferred skills
Advanced degrees (Master's or PhD), Regional regulatory certifications (RAC, CARP, CHPC).
Technologies
Module 1 documentation, national regulatory systems.
Responsibilities
Collaborate on regulatory strategy decisions, develop and execute registration/lifecycle strategies, ensure compliance with ANZ requirements, represent company in industry forums, lead in-country regulatory processes, prepare regulatory documentation, manage compliant labelling and promotional materials.
Seniority
Director, strategic leadership & team guidance
