Country Head, Regulatory Affairs, Australia and New Zealand

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 regulatory dossiers including Information for Professionals and Patient and Packaging Information.

• Strong knowledge of Australian (TGA) and New Zealand (Medsafe) regulatory frameworks, with a solid understanding of local public health needs

• Proven experience in defining and executing regulatory strategies across the product lifecycle, including development and post-approval phases, with knowledge of global regulatory environments

• Strong understanding of CMC regulatory requirements, with the ability to effectively engage with technical experts and health authorities on manufacturing, quality, and inspection-related topics for biologics and vaccines.

• Demonstrated success in leading major regulatory submissions and high-impact health authority interactions

• Strong understanding of global regulatory frameworks (e.g., CTD) and their application across regions

• Proven ability to operate effectively in a global, matrixed organization, influencing cross-functional teams and senior stakeholders

• Ability to identify, assess, and mitigate regulatory risks, aligning regulatory strategies with business objectives

• Excellent communication, negotiation, and stakeholder management skills, with the ability to represent the organization externally

• Ability to navigate complexity and manage multiple priorities in a fast-paced, evolving environment

• Experience in relevant therapeutic areas is preferred, particularly in vaccines and infectious diseases, as well as emerging areas aligned with Moderna’s pipeline such as rare diseases, oncology, and immune-mediated diseases

• A desire to be part of a transformational company that is Bold, Relentless, Curious, and Collaborative

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our global benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Best-in-class healthcare, plus voluntary benefit programs to support your unique needs

• A holistic approach to well-being with access to fitness, mindfulness, and mental health support

• Family building benefits, including fertility, adoption, and surrogacy support

• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown

• Savings and investments to help you plan for the future

• Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.  

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. 

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. 

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. 

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. 

Moderna is a smoke-free, alcohol-free, and drug-free work environment. 

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! 

Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. 

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. 

Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com. 

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