Regulatory Affairs Manager ANZ
Core
Leads the regulatory function for Australia and New Zealand, accountable for product registration, maintenance, and compliance with TGA and Medsafe requirements.
Role type
Senior IC Regulatory Affairs Manager
Builds
Regulatory strategies, product registrations, and lifecycle management for the ANZ portfolio
Domain
Pharmaceutical regulatory affairs in Australia and New Zealand
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic planning, team leadership, regulatory submission management, risk assessment, commercial portfolio evaluation, stakeholder management, project management, budget management
Preferred skills
Experience with business development, due diligence, and market access strategies
Technologies
TGA, Medsafe
Responsibilities
Manage and develop the ANZ Regulatory Affairs team; develop and execute regulatory strategies for timely registration; oversee preparation and submission of applications to TGA and Medsafe; provide strategic input to business development and portfolio planning; ensure compliance with applicable legislation and internal procedures; manage client and partner relationships; support audits and inspection readiness.
Seniority
Senior, hands-on IC with leadership responsibilities
