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 Recent 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 New 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