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



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




Experience supporting business development activities, client engagements, business case evaluations and commercial decision-making.
Ability to contribute effectively as a member of an Extended Leadership Team, driving organisational objectives, collaboration and continuous improvement.
Core Competencies
Demonstrates extensive knowledge of TGA and Medsafe requirements, with a robust 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.
Highest-signal resume keywords
Regulatory Affairs Leadership
TGA and Medsafe Compliance
Regulatory Submissions Management
Strategic Risk Assessment
Project Management
Hard Skills
Regulatory Strategy Development
Regulatory Risk Assessment
Regulatory Submissions
Product Lifecycle Management
Quality Management Activities
Regulatory Metrics Development
Pharmacovigilance
Change Control
Continuous Improvement
Market Access Compliance
Soft Skills
Communication Skills
Stakeholder Management
Negotiation Skills
Team Leadership
Organisational Skills
Certifications & Qualifications
Bachelor's Degree in Pharmacy
Bachelor's Degree in Life Sciences
Bachelor's Degree in Biomedical Science
Industry Keywords
Pharmaceutical Regulatory Affairs
Australia and New Zealand Regulatory Activities
Commercial Strategy
Business Development
Inspection Readiness
Tools & Technologies
Regulatory Dashboards
Submission Trackers
Performance Reporting Tools
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📌 Regulatory Affairs Manager (Sydney)
🏢 Jobtailor
📍 Sydney