About the Role We are partnering with an established global biopharmaceutical organisation to appoint a Director, Regulatory Affairs for Australia and New Zealand. Based in Melbourne, this role sits within the company's Global Regulatory Affairs function and forms part of a broader regional team. This is a newly created leadership position offering a clear step-up to a regional remit. You will lead the local regulatory team, act as the primary external interface with local health authorities and industry bodies, and shape regulatory strategy across a diverse specialty portfolio. Key Responsibilities Lead and develop the local regulatory team, supporting day-to-day decision-making and acting as the first point of escalation. Build and grow a high-performing team, attracting talent and developing capability across the function. Serve as the primary interface with relevant health authorities, government bodies and industry associations. Develop and execute innovative regulatory strategies for new product registrations, lifecycle management and launches. Ensure strict compliance with local regulations, leading audit and inspection readiness. Partner closely with Commercial Operations, Medical and other cross-functional stakeholders to translate regulatory insight into actionable business plans. Provide expert review of promotional materials, labelling and product information in line with local legislation. Represent the organisation in industry forums and policy activities, sharing insights and best practice. About You 10+ years of regulatory affairs experience in the pharmaceutical or biotech industry, including significant time in a health-authority-facing role. Demonstrated leadership experience, including building and managing high-performing teams. In-depth knowledge of the Australian regulatory environment; New Zealand exposure highly regarded. Specialty biologics experience well regarded. Strong commercial acumen and a track record of working cross-functionally with Medical, Commercial and Pharmacovigilance teams. Excellent stakeholder management skills and the ability to influence at all levels in a complex, global matrix environment. Bachelor's degree in a relevant scientific discipline What’s on Offer Hybrid working arrangement based out of Melbourne. The opportunity to shape regulatory strategy for a globally significant portfolio. Genuine regional career progression within a respected regional team #J-18808-Ljbffr