Job Description
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Lead the regulatory function for Australia and New Zealand and oversee registration, maintenance and compliance of the company's product portfolio.
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Develop and implement regulatory strategies supporting business objectives and applicable legislation.
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Lead, coach and develop the ANZ Regulatory Affairs team.
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Establish priorities, allocate workloads and provide technical guidance for complex regulatory matters.
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Oversee preparation, review and submission of applications to the TGA and Medsafe.
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Ensure timely approvals for registrations, variations, notifications and renewals.
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Manage product transfers, acquisitions, divestments and lifecycle activities.
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Track and fulfil regulatory commitments, approvals and post-approval obligations.
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Provide regulatory input into commercial strategy, portfolio planning, market expansion and business development.
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Prepare regulatory risk assessments, pathway evaluations and timeline projections.
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Maintain inspection readiness and support audits.
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Contribute to quality management activities, including CAPAs, change controls and continuous improvement.
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Collaborate with Commercial, Medical Affairs, Quality, Supply Chain, Pharmacovigilance and Business Development teams.
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Advise partners, clients and external stakeholders on regulatory pathways, compliance and market access.
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Lead partner meetings, business reviews and strategic planning discussions.
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Review regulatory, pharmacovigilance, quality and technical services agreements.
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Support regulatory budgets, resource plans, invoicing and operational management.
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Develop regulatory metrics, dashboards, performance reporting and submission trackers.
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Requirements
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Bachelor's degree in Pharmacy,



Life Sciences, Biomedical Science or a related scientific discipline.
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Minimum 8-10 years' experience in pharmaceutical regulatory affairs, including responsibility for Australia and New Zealand regulatory activities.
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Extensive knowledge of TGA and Medsafe requirements, with proven experience managing regulatory submissions across the product lifecycle.
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Demonstrated experience leading, developing and mentoring regulatory professionals.
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Strong strategic thinking, with the ability to assess regulatory risks, opportunities and commercial implications to support business decisions.
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Experience supporting business planning, portfolio strategy, due diligence and evaluation of new product opportunities.
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Strong project management, organisational and prioritisation skills.
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Excellent communication, presentation, stakeholder management and negotiation skills.
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Ability to analyse and communicate complex scientific, regulatory and commercial information to technical and non-technical audiences.
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Strong commercial awareness and the ability to balance business objectives with regulatory compliance requirements.
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Demonstrated ability to build trusted relationships with senior stakeholders, clients, partners and regulatory authorities.
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Experience supporting business development activities, client engagements,



business case evaluations and commercial decision-making.
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Ability to contribute effectively as a member of an Extended Leadership Team, driving organisational objectives, collaboration and continuous improvement.
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Core Competencies
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Demonstrates extensive knowledge of TGA and Medsafe requirements, with a strong background in pharmaceutical regulatory affairs and a proven ability to lead and develop regulatory teams. Capable of strategic thinking and risk assessment to align regulatory compliance with business objectives.
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Highest-signal resume keywords
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Regulatory Affairs Leadership
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TGA and Medsafe Compliance
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Regulatory Submissions Management
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Strategic Risk Assessment
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Project Management
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Hard Skills
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Regulatory Strategy Development
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Regulatory Risk Assessment
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Regulatory Submissions
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Product Lifecycle Management
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Quality Management Activities
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Regulatory Metrics Development
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Pharmacovigilance
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Change Control
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Continuous Improvement
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Market Access Compliance
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Soft Skills
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Communication Skills
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Stakeholder Management
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Negotiation Skills
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Team Leadership
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Organisational Skills
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Certifications & Qualifications
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Bachelor's Degree in Pharmacy
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Bachelor's Degree in Life Sciences
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Bachelor's Degree in Biomedical Science
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Industry Keywords
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Pharmaceutical Regulatory Affairs
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Australia and Current Zealand Regulatory Activities
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Commercial Strategy
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Business Development
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Inspection Readiness
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Tools & Technologies
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Regulatory Dashboards
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Submission Trackers
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Performance Reporting Tools
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📌 Regulatory Affairs Manager (New South Wales)
🏢 Jobtailor
📍 New South Wales