Country Head, Regulatory Affairs, Australia and New Zealand

About the role

Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is strengthening its presence in Melbourne, a leading biotech hub in Australia. Our team drives commercial operations to bring our mRNA medicines to patients nationwide. We welcome global professionals committed to making a meaningful impact. As the senior regulatory leader for Australia and New Zealand, this role defines and drives local regulatory strategy in alignment with global priorities, ensuring seamless execution from development through lifecycle management. You will operate at the intersection of global strategy, local regulatory execution, and public health priorities-playing a critical role in enabling innovative mRNA medicines and vaccines. This position is central to advancing Moderna's strategic partnership with the Australian Government, including supporting the establishment and evolution of local mRNA manufacturing capabilities in Melbourne. 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 Serve as the primary interface with the Therapeutic Goods Administration (TGA) and Medsafe, leading high-impact engagements, scientific advice discussions, 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 Translate global development, CMC, and lifecycle strategies into successful local approvals and sustained compliance across both Australia and New Zealand Provide regulatory leadership and strategic guidance for local drug substance and drug product manufacturing initiatives, including alignment of CMC strategies with local regulatory requirements, site licensure, inspection readiness, and lifecycle management for products manufactured in Melbourne Play a key role in supporting Moderna's strategic partnership with the Australian Government, enabling local vaccine production and strengthening regional health security through regulatory expertise Provide regulatory input and enable local research and clinical collaborations, supporting innovative development approaches across Australia and New Zealand Contribute to shaping the external regulatory environment through engagement with health authorities, industry associations, and policy forums-particularly advancing frameworks for innovative platforms such as mRNA Identify, assess, and proactively manage regulatory risks, developing mitigation strategies that support business objectives and long-term success Lead and develop the local regulatory strategy team, fostering a high-performing, agile, and collaborative environment Represent Australia and New Zealand in global regulatory and cross-functional forums, ensuring integration of local requirements into global strategies while influencing decision-making Partner closely with the General Manager of the Australia/New Zealand Affiliate and collaborate cross-functionally with Clinical, Quality, Manufacturing, Medical, and Commercial teams to support development, market access, and successful product launches Work closely with global regulatory, CMC, and cross-functional teams to ensure alignment between local execution and global development plans while proactively advocating for regional needs Support the business in securing appropriate operating licenses and provide regulatory guidance to enable overall business plans, including market access strategies Communicate regulatory strategies, risks, and plans effectively to senior leadership and stakeholders, both internally and externally Leverage digital innovation and emerging technologies, including opportunities to engage with AI-driven regulatory tools, to enhance regulatory intelligence, submissions, and execution Support the Moderna Regional Research Centre for respiratory medicines and tropical diseases (based in Victoria, Australia) on public medicine regulatory policy for South-East Asia region The key Moderna Mindsets you'll need to succeed in the role: We act with urgency; Action today compounds the lives saved tomorrow. We behave like owners. The solutions we're building go beyond any job description. Here's What You'll Need (Basic Qualifications) Degree in Life Sciences or related discipline, advanced degree preferred (PharmD, MSc, PhD or equivalent) Extensive experience in Regulatory Affairs within the pharmaceutical/biotech industry (typically 15+ years), including significant experience in regulatory strategy Demonstrated leadership experience, including building, leading, and developing high-performing regulatory teams whose remit will be to create and maintain the Australian-specific parts of regulato