- 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.
- Robust 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 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.

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