Regulatory Affairs Manager ANZ

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 ResponsibilitiesLeadership and People ManagementManage, lead, coach and develop the ANZ Regulatory Affairs teamEstablish priorities, allocate workloads and ensure effective resource utilisationFoster a collaborative, high-performing and quality-focused team cultureProvide technical guidance and escalation support for complex regulatory mattersDrive individual and team development through mentoring, coaching and succession planningActively contribute as a member of the ANZ Extended Leadership Team. Regulatory StrategyDevelop and execute regulatory strategies to support timely registration and lifecycle managementIdentify regulatory risks and opportunities and provide strategic recommendations to internal stakeholders and partnersProvide regulatory input into commercial strategy, portfolio planning and market expansion opportunitiesMonitor regulatory developments and assess business impactEnsure regulatory strategies align with organisational objectives and compliance requirements. Product Registration and Lifecycle ManagementOversee preparation, review and submission of regulatory applications to the TGA and MedsafeEnsure timely approval of new registrations, variations, notifications and renewal applicationsProvide strategic oversight of product transfers, acquisitions and divestmentsEnsure regulatory commitments, approvals and post-approval obligations are tracked and fulfilledLead management of critical regulatory projects and submissionsEnsure regulatory deliverables are executed to agreed quality standards and timelines. Business Development and Portfolio EvaluationProvide strategic input to business development initiatives, product acquisitions/divestments and portfolio expansionReview business cases by providing regulatory, compliance, timing, cost, market access and operational considerationsPrepare regulatory risk assessments, pathway evaluations and timeline projections to support commercial decision-makingIdentify opportunities to maximise regulatory exclusivity, expedited pathways and lifecycle valueCompliance and QualityEnsure regulatory activities are conducted in accordance with applicable legislation, guidelines and internal proceduresMaintain inspection readiness and support audits where requiredEnsure accurate and compliant maintenance of regulatory documentation, records and databasesContribute to quality management system activities, including CAPAs, change controls and continuous improvement initiativesPromote a culture where quality, compliance and risk management are embedded in daily activitiesSupport implementation of regulatory and quality process improvements. Cross-Functional CollaborationPartner with Commercial, Medical Affairs, Quality, Supply Chain, Pharmacovigilance and Business Development teamsProvide regulatory guidance for product launches, artwork updates, manufacturing changes and commercial initiativesSupport cross-functional business planning, forecasting and portfolio review activitiesEnsure regulatory risks, opportunities and compliance requirements are effectively communicated to internal stakeholdersBuild collaborative relationships that facilitate efficient and compliant delivery of business objectives. Partner and Client Relationship ManagementDevelop and maintain strong relationships with partners, clients and external stakeholders to support business objectives and high-quality service deliveryAct as a trusted regulatory adviser on regulatory pathways, compliance requirements and market access considerationsLead and participate in partner meetings, business reviews and strategic planning discussionsManage client expectations, agreed scope, timelines and deliverables through proactive communicationIdentify opportunities to strengthen existing partnerships and enhance service deliveryEscalate and resolve regulatory or service delivery issues using a collaborative and solutions-focused approachPromote the organisation's regulatory expertise and service capabilities through professional client engagement. Contract Review and ManagementProvide 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 impactCollaborate with internal stakeholders and external partners to define and negotiate regulatory roles, responsibilities and deliverablesEnsure contractual commitments align with regulatory requirements, agreed service scope and organisational capabilityMonitor regulatory obligations arising from contracts and escalate risks, changes or potential non-complianceSupport management of regulatory service scope, contractual deliverables and change requests. Financial and Operational ManagementSupport 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 qualityAdministration and Operational ExcellenceEnsure regulatory activities are appropriately tracked, documented and reportedManage agency fees, consultant engagement and regulatory expenditure where applicableDevelop and maintain regulatory metrics, dashboards and performance reportingSupport implementation of systems and processes that improve regulatory efficiency, compliance and transparencyEnsure accurate maintenance of regulatory records, databases and submission trackersRequirementsBachelor'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