Health and Aged Care Professionals - Sydney NSWFull time19d ago , from Health and Aged Care ProfessionalsBenefitsANZ leadership role with genuine strategic influenceLead and develop an established Regulatory Affairs teamBroad exposure across new registrations, lifecycle management and portfolio growthJoin a growing healthcare business with an expanding portfolio and pipelineAbout the companyThis established healthcare organisation operates across Australia and New Zealand, partnering with a broad range of products and businesses across the pharmaceutical sector.
With continued growth across the region, the business offers a fast-moving and commercially focused environment where Regulatory Affairs plays an important role in portfolio strategy, new opportunities and successful product launches.About the opportunityAn exciting opportunity has become available for an experienced Regulatory Affairs leader to take responsibility for the ANZ regulatory function.
Leading a small team, you will oversee regulatory strategy and execution across Australia and New Zealand while remaining close to key submissions, new registrations and complex regulatory projects.
This is broader than a traditional Regulatory Affairs management position.
You will work closely with senior leadership, commercial teams and external partners to assess new opportunities, shape regulatory strategy and provide guidance around pathways, timelines, risk and feasibility.
The role would suit someone who enjoys leading people but still wants to remain connected to the technical and strategic side of Regulatory Affairs.DutiesLead,



coach and develop the Regulatory Affairs teamSet priorities and oversee regulatory workload across the portfolioDevelop regulatory strategies for current product registrations and lifecycle activitiesProvide oversight of submissions to the TGA and MedsafeSupport new registrations, variations, transfers and post-approval activitiesLead complex or business-critical regulatory projectsProvide regulatory input into new product opportunities, portfolio expansion and business casesAssess regulatory pathways, timelines, risks and resource requirements for prospective opportunitiesPartner with Commercial, Medical Affairs, Quality, Pharmacovigilance, Supply Chain and Business DevelopmentBuild strong relationships with external partners and provide strategic regulatory adviceSupport regulatory aspects of product launches, manufacturing changes and artwork updatesContribute to regulatory process improvement, compliance and inspection readinessMonitor team resources, project requirements and regulatory service deliveryContribute to broader ANZ leadership discussions and business planningSkills and ExperienceExtensive pharmaceutical Regulatory Affairs experience across the Australian marketStrong knowledge of TGA regulatory requirements and ideally experience across New Zealand/MedsafeDemonstrated experience managing new registrations as well as ongoing lifecycle activitiesPrevious people leadership experience, including coaching and developing regulatory professionalsComfortable remaining hands-on and providing technical guidance when requiredStrong understanding of regulatory strategy and the commercial implications of regulatory decisionsStrong stakeholder management skills with the confidence to work with senior internal and external stakeholdersAble to manage multiple priorities within a changing and commercially focused environmentProactive, solutions-focused and comfortable taking ownershipCultureJoin a collaborative and agile environment where Regulatory Affairs has strong visibility across the wider business.
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📌 Regulatory Affairs Manager (Sydney)
🏢 Health and Aged Care Professionals
📍 Sydney