Country Head, Regulatory Affairs, Australia and New Zealand
Core
Define and drive local regulatory strategy for mRNA medicines and vaccines in Australia and New Zealand, ensuring alignment with global priorities and enabling local manufacturing capabilities.
Role type
Senior regulatory leader (Country Head)
Builds
Local regulatory strategy, regulatory submissions, and manufacturing site licensure for mRNA products
Domain
Biopharmaceuticals / mRNA technology / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy, lifecycle management, CMC regulatory requirements, health authority engagement, risk assessment, team leadership, global regulatory frameworks (CTD)
Preferred skills
Vaccines and infectious diseases experience, rare diseases, oncology, immune-mediated diseases
Technologies
AI-driven regulatory tools
Responsibilities
Define and lead local regulatory strategy; serve as primary interface with TGA and Medsafe; oversee regulatory submissions and lifecycle activities; translate global strategies into local approvals; provide leadership for local manufacturing initiatives; support strategic partnership with Australian Government; enable local research collaborations; shape external regulatory environment; manage regulatory risks; lead and develop the local regulatory team; represent region in global forums; partner cross-functionally with Clinical, Quality, Manufacturing, Medical, and Commercial teams; secure operating licenses.
Seniority
Senior, hands-on IC with strategic leadership
