Country Head, Regulatory Affairs, Australia and New Zealand

Job description

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 o...