Job Description

The Regulatory Affairs Manager ANZ leads the regulatory function for Australia and New Zealand and is accountable for the registration, maintenance and compliance of the company’s product portfolio.

The role combines scientific, regulatory, commercial and partner-facing expertise to develop and implement regulatory strategies that support business objectives while ensuring compliance with applicable legislation and regulatory requirements. The role leads and develops the ANZ regulatory team and acts as a trusted adviser to partners and internal stakeholders.

The position contributes to strategic business planning, business development and portfolio evaluation by identifying regulatory risks, opportunities, costs, timelines and market access considerations. It supports high-quality service delivery, effective partner management and efficient execution of new registrations and lifecycle activities.

Key Responsibilities

Leadership and People Management

• Manage, lead, coach and develop the ANZ Regulatory Affairs team.
• Establish priorities, allocate workloads and ensure effective resource utilisation.
• Foster a collaborative, high-performing and quality-focused team culture.
• Provide technical guidance and escalation support for complex regulatory matters.
• Drive individual and team development through mentoring, coaching and succession planning.
• Actively contribute as a member of the ANZ Extended Leadership Team.

Regulatory Strategy

• Develop and execute regulatory strategies to support timely registration and lifecycle management.
• Identify regulatory risks and opportunities and provide strategic recommendations to internal stakeholders and partners.
• Provide regulatory input into commercial strategy, portfolio planning and market expansion opportunities.
• Monitor regulatory developments and assess business impact.
• Ensure regulatory strategies align with organisational objectives and compliance requirements.

Product Registration and Lifecycle Management

• Oversee preparation, review and submission of regulatory applications to the TGA and Medsafe.
• Ensure timely approval of new registrations, variations, notifications and renewal applications.
• Provide strategic oversight of product transfers, acquisitions and divestments.
• Ensure regulatory commitments, approvals and post-approval obligations are tracked and fulfilled.
• Lead management of critical regulatory projects and submissions.
• Ensure regulatory deliverables are executed to agreed quality standards and timelines.

Business Development and Portfolio Evaluation

• Provide strategic input to business development initiatives, product acquisitions/divestments and portfolio expansion.
• Review business cases by providing regulatory, compliance, timing, cost, market access and operational considerations.
• Prepare regulatory risk assessments, pathway evaluations and timeline projections to support commercial decision-making.
• Identify opportunities to maximise regulatory exclusivity, expedited pathways and lifecycle value.

Compliance and Quality

• Ensure regulatory activities are conducted in accordance with applicable legislation, guidelines and internal procedures.
• Maintain inspection readiness and support audits where required.
• Ensure accurate and compliant maintenance of regulatory documentation, records and databases.
• Contribute to quality management system activities, including CAPAs, change controls and continuous improvement initiatives.
• Promote a culture where quality, compliance and risk management are embedded in daily activities.
• Support implementation of regulatory and quality process improvements.

Cross-Functional Collaboration

• Partner with Commercial, Medical Affairs, Quality, Supply Chain, Pharmacovigilance and Business Development teams.
• Provide regulatory guidance for product launches, artwork updates, manufacturing changes and commercial initiatives.
• Support cross-functional business planning, forecasting and portfolio review activities.
• Ensure regulatory risks, opportunities and compliance requirements are effectively communicated to internal stakeholders.
• Build collaborative relationships that facilitate efficient and compliant delivery of business objectives.

Partner and Client Relationship Management

• Develop and maintain strong relationships with partners, clients and external stakeholders to support business objectives and high-quality service delivery.
• Act as a trusted regulatory adviser on regulatory pathways, compliance requirements and market access considerations.
• Lead and participate in partner meetings, business reviews and strategic planning discussions.
• Manage client expectations, agreed scope, timelines and deliverables through proactive communication.
• Identify opportunities to strengthen existing partnerships and enhance service delivery.
• Escalate and resolve regulatory or service delivery issues using a collaborative and solutions-focused approach.
• Promote the organisation's regulatory expertise and service capabilities through professional client engagement.

Contract Review and Management

• Provide regulatory review and input into regulatory, pharmacovigilance, quality and technical services agreements where required.
• Assess contractual obligations for regulatory feasibility, compliance, resource requirements and operational impact.
• Collaborate with internal stakeholders and external partners to define and negotiate regulatory roles, responsibilities and deliverables.
• Ensure contractual commitments align with regulatory requirements, agreed service scope and organisational capability.
• Monitor regulatory obligations arising from contracts and escalate risks, changes or potential non-compliance.
• Support management of regulatory service scope, contractual deliverables and change requests.

Financial and Operational Management

• Support monthly review of regulatory budgets and resource plans.
• Ensure accurate and timely monthly invoicing in accordance with contractual requirements.
• Monitor resource allocation and utilisation across ANZ regulatory activities.
• Ensure delivery of regulatory services within agreed scope, timelines and budget.
• Assess regulatory resource requirements for prospective business opportunities and client engagements.
• Drive continuous improvement initiatives to enhance efficiency, consistency and service quality.

Administration and Operational Excellence

• Ensure regulatory activities are appropriately tracked, documented and reported.
• Manage agency fees, consultant engagement and regulatory expenditure where applicable.
• Develop and maintain regulatory metrics, dashboards and performance reporting.
• Support implementation of systems and processes that improve regulatory efficiency, compliance and transparency.
• Ensure accurate maintenance of regulatory records, databases 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.