Country Head, Regulatory Affairs, Australia and New Zealand

The Role The Country Head, Regulatory Affairs – Australia and New Zealand, based in Melbourne, is responsible for defining and leading local regulatory strategy and execution across Australia and New Zealand, in alignment with global regulatory strategies. This role serves as the primary interface with the Therapeutic Goods Administration (TGA) and Medsafe, ensuring effective execution of global development, CMC, and lifecycle strategies into successful local approvals and sustained compliance. A key accountability of the role is to provide regulatory leadership supporting Moderna’s strategic partnership with the Australian Government, including the establishment and evolution of local mRNA manufacturing capabilities in Melbourne. This includes facilitating the development, approval, and lifecycle management of vaccines manufactured both globally and locally. The role also provides regulatory input on local research and clinical collaborations , enabling innovative development approaches within Australia and New Zealand. Reporting to the Executive Director, Regulatory Strategy, Resilience markets (currently UK, Canada and Australia) and partnering closely with the General Manager of the Australia/New Zealand Affiliate, the Country Head will lead the local regulatory strategy team and represent Australia and New Zealand within global regulatory and cross-functional discussions. This person will work closely with the business in Australia to secure the appropriate operating licenses and provide the regulatory guidance to support the overall business plans including market access. This position requires a strategic and agile Senior Director capable of operating at the intersection of global strategy, local execution, and public health priorities, particularly in the context of innovative platforms such as mRNA. Here's What You’ll Do Define and lead local regulatory strategy across Australia and New Zealand, ensuring alignment with global regulatory strategies while driving optimal local outcomes Provide regulatory leadership for interactions with TGA and Medsafe, including high-impact engagements, scientific advice, and negotiation of regulatory pathways Oversee the planning, preparation, and execution of regulatory submissions and lifecycle activities, ensuring quality, compliance, and timely delivery across development and marketed products Provide regulatory support and strategic guidance for local drug substance and drug product manufacturing initiatives, ensuring alignment of CMC strategies with local regulatory requirements, including site licensure, inspection readiness, and lifecycle management for the products manufactured in Melbourne. Support Moderna’s strategic partnership with the Australian Government, contributing regulatory expertise to enable local vaccine production and strengthen regional health security Contribute to shaping the external regulatory environment, engaging with health authorities, industry associations, and policy forums to help influence evolving regulatory frameworks, particularly for innovative platforms such as mRNA Enable regulatory support for local research and clinical collaborations, facilitating innovative development approaches within Australia and New Zealand Identify and proactively manage regulatory risks, providing strategic guidance and mitigation plans to support business objectives Lead and develop the local regulatory strategy team, fostering a high-performing and collaborative environment Represent Australia and New Zealand in global regulatory and cross-functional forums, ensuring effective integration of local requirements into global plans Partner cross-functionally with Clinical, Quality, Manufacturing, Medical, and Commercial team as part of the Australian leadership team to support development, market access, and successful product launches Collaborate closely with global regulatory, CMC, and cross-functional teams to ensure alignment of local strateg ... (truncated, view full listing at source)