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 Modernas 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.

Heres What Youll 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 Modernas 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 strategies with global development plans while proactively representing regional needs and influencing global decision-making

• Communicate regulatory strategies risks and plans to senior leadership and stakeholders both internally and externally

Heres What Youll 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 Modernas 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. Thats why our global benefits and well-being resources are designed to support youat 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

• Savingsandinvestments 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 theinfrastructure 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 peopleare the driving force behind our scientific progress and our 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 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 persons 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.

Were 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 .

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