Benefits Build a track record managing your own portfolio of clinical trials Expand your clinical leadership experience – whether you're stepping up or already leading Grow your professional network with global pharmaceutical and biotech sponsors Stay close to patients and clinical delivery as your career progresses About the Company Join a growing Sydney-based clinical research organisation delivering complex clinical trials for pharmaceutical and biotechnology sponsors. Based within a dedicated clinical trials facility, you'll be surrounded by experienced clinical, pharmacy, laboratory and research professionals in an environment where your contribution is genuinely seen and valued. About the Opportunity Take ownership of a portfolio of clinical trials and lead a team of Clinical Trial Coordinators, building the leadership experience and sponsor relationships that strengthen your clinical research career. For an experienced Clinical Project Manager or Clinical Trials Manager, it's a chance to broaden your influence. For an accomplished Senior Clinical Trial Coordinator, it's the opportunity to step beyond coordination into genuine project and people leadership. What You'll Be Doing Managing a portfolio of clinical trials from start to finish Leading, coaching and developing a team of Clinical Trial Coordinators Acting as the key point of contact for sponsors and investigators Resolving study challenges and keeping trials on track under pressure Why It's Worth It Step up in scope and seniority without losing the parts of the job you love Build genuine people-leadership experience within clinical research Get the autonomy to lead, backed by an experienced team around you Join a close-knit, high-accountability team where good contributions get noticed What You'll Bring Strong clinical trials experience, with prior coordination and/or leadership exposure Confidence engaging directly with sponsors and investigators Sound judgement and the ability to solve problems under pressure Experience across early-phase, oncology or healthy-volunteer trials is highly regarded; other strong clinical trial backgrounds are also welcome Culture You'll be trusted to make decisions, contribute ideas and lead from the front. Based in Randwick, Sydney, you'll stay close to the people, patients and studies you lead. Ready for greater responsibility and influence in your clinical research career? Apply now, or reach out directly for a confidential conversation. How to Apply Click apply or contact Eve Cooke, Senior Recruitment Consultant on 02 8877 8722 for a confidential discussion. About Healthcare Professionals Group Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care. Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific; Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs; Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse; Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing. For more job opportunities, visit www.hpgconnect.com.
Benefits • ANZ leadership role with genuine strategic influence • Lead and develop an established Regulatory Affairs team • Broad exposure across new registrations, lifecycle management and portfolio growth • Join a growing healthcare business with an expanding portfolio and pipeline About the company This 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 opportunity An 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. Duties • Lead, coach and develop the Regulatory Affairs team • Set priorities and oversee regulatory workload across the portfolio • Develop regulatory strategies for new product registrations and lifecycle activities • Provide oversight of submissions to the TGA and Medsafe • Support new registrations, variations, transfers and post-approval activities • Lead complex or business-critical regulatory projects • Provide regulatory input into new product opportunities, portfolio expansion and business cases • Assess regulatory pathways, timelines, risks and resource requirements for prospective opportunities • Partner with Commercial, Medical Affairs, Quality, Pharmacovigilance, Supply Chain and Business Development • Build strong relationships with external partners and provide strategic regulatory advice • Support regulatory aspects of product launches, manufacturing changes and artwork updates • Contribute to regulatory process improvement, compliance and inspection readiness • Monitor team resources, project requirements and regulatory service delivery • Contribute to broader ANZ leadership discussions and business planning Skills and Experience • Extensive pharmaceutical Regulatory Affairs experience across the Australian market • Strong knowledge of TGA regulatory requirements and ideally experience across New Zealand/Medsafe • Demonstrated experience managing new registrations as well as ongoing lifecycle activities • Previous people leadership experience, including coaching and developing regulatory professionals • Comfortable remaining hands-on and providing technical guidance when required • Strong understanding of regulatory strategy and the commercial implications of regulatory decisions • Strong stakeholder management skills with the confidence to work with senior internal and external stakeholders • Able to manage multiple priorities within a changing and commercially focused environment • Proactive, solutions-focused and comfortable taking ownership Culture Join a collaborative and agile environment where Regulatory Affairs has strong visibility across the wider business. How to Apply Ready to take the next step? Click apply or contact Gemma Staddon on gstaddon@hpgconnect.com for a confidential discussion. About Healthcare Professionals Group Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care. • Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific • Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs • Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse • Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing
