Senior Manager Regulatory Affairs (Contract)

This is a 12-month fixed-term contract for a Senior Regulatory Affairs Manager role. Within this role, the person acts as the Regional Regulatory Affairs Lead for Australia and New Zealand regulatory projects, supporting and leading assigned priority projects from feasibility assessment through submission, approval and lifecycle management, while working closely with the Global Regulatory Affairs Lead, Global Safety Leads, global project teams, local Commercial, Medical, Quality Assurance, Supply Chain and external partners to deliver compliant, timely and commercially aligned regulatory outcomes.
The role provides senior regulatory support across assigned products and projects, including TGA and Medsafe engagement, regulatory feasibility assessment, strategy development, health authority responses and use of Veeva RIM Vault to manage regulatory information, submission records and approval documentation. Priorities, deliverables and escalation pathways will be agreed upfront with the Director Scientific Affairs, with regular check-ins to support effective workload management and alignment to business needs.
Any Quality Assurance or Pharmacovigilance back-up support will be limited to defined activities, subject to appropriate training, documented delegation and oversight by the responsible function.
A structured handover and onboarding period will be provided to ensure the successful candidate understands current projects, systems, key stakeholders and agreed priorities. Given the fixed-term nature of the role, the focus will be on agreed priority projects and business-critical regulatory deliverables rather than full ownership of all regulatory activities.