Country Head, Regulatory Affairs, Australia and New Zealand at Moderna

Melbourne, Victoria, Australia -

Full Time

Start Date

Immediate

Expiry Date

12 Jul, 26

Salary

0.0

Posted On

13 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory strategy, TGA regulatory framework, Medsafe regulatory framework, CMC regulatory requirements, Lifecycle management, Vaccine development, mRNA technology, Stakeholder management, Regulatory submissions, Health authority interaction, Biologics, Clinical collaboration, Risk mitigation, Team leadership, Strategic planning, Public health policy

Industry

Biotechnology Research

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 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 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 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. - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home

Responsibilities

The Country Head will lead local regulatory strategy and execution for Australia and New Zealand, serving as the primary interface with the TGA and Medsafe. They will also provide regulatory leadership for local mRNA manufacturing initiatives and support strategic partnerships with the Australian Government.