Senior Regulatory Affairs Specialist

Job description

Are you ready to bring your expertise and knowledge in Australian regulatory affairs, GMO requirements and OGTR submissions to help transform ground breaking science into life-changing medicines? At AstraZeneca, you will be part of a bold, collaborative team. This team follows the science, turns ideas into meaningful impact, and works daily to bring transformative medicines to those in need. ## **About AstraZeneca** AstraZeneca is a global, science-led biopharmaceutical company focused on the discovery, development and commercialisation of prescription medicines, primarily across Oncology, Cardiovascular, Renal and Metabolism, Respiratory & Immunology, and Rare Disease. At AstraZeneca Australia, we have worked for more than 60 years to deliver the best value to patients. We advance the frontiers of science to provide life-changing medicines. ## **Regulatory Affairs At AstraZeneca** This is an exciting opportunity to join AstraZeneca during a dynamic period of growth, working with groundbreaking science through innovative clinical trials in cell and gene therapy. In this role, you will lead the submissions to the Office of the Gene Technology Regulator (OGTR). You will ensure that the genetically modified organism (GMO) components are accurately regulated and approved for human studies. You’ll join an exciting, encouraging, and highly collaborative group passionate about Regulatory Affairs. You can apply your expertise, grow your knowledge, and make a meaningful impact. This position offers the chance to work locally and globally with clinical, regulatory, and other cross-functional teams. You will partner with experienced experts to develop innovative clinical trial pathways. You’ll also actively contribute to early-phase discussions with local and global experts on bringing cell and gene therapies to Australia for clinical trials. This work helps turn groundbreaking science into transformative treatments for patients. This is a 2-year full-time Maximum Term contract position based in Macquarie Park Sydney. It offers hybrid working with 3 days in the office per week and reports to the Senior Regulatory Affairs Manager. ## **What you’ll do** As Senior Regulatory Affairs Specialist, you’ll prepare and implement regulatory submission plans for clinical trial projects and products. This role helps enable clinical studies and supports strategies to register or maintain products in Australia. You will: - Provide operational and tactical regulatory input on Australian GMO requirements for clinical trials and commercial products, including classification of proposed dealings and approval pathways. - Coordinate high-quality, scientifically robust and compliant submission packages, including DNIR and DIR applications, in collaboration with global regulatory and functional leads. - Work closely with Australian clinical colleagues, study teams, clinical sites, IBCs and OGTR consultants to support GMO submissions and study start-up. - Monitor and communicate progress, risks, issues and upcoming milestones for regulatory applications and activities. - Build effective relationships with OGTR, TGA, IBCs, clinical sites and other collaborators to support timely review, approval and compliant GMO dealings. - Maintain awareness of Australian and relevant international regulatory guidelines, helping find opportunities and manage potential risks. ## **Essential for the role** - University degree in science or a related discipline, with experience in Regulatory Affairs, clinical research, biosafety or a related healthcare or pharmaceutical area. - Experience or strong exposure to Australian GMO requirements, including OGTR expectations for DNIR and DIR applications. - Experience supporting GMO clinical trials and/or commercial product regulatory activities in Australia. - Experience or solid awareness of TGA submissions and the Australian regulatory environment. - Excellent written and verbal communication skills, with strong attention to detail, analytical thinking and critical thinking capability. - Ability to work effectively across multidisciplinary teams and deliver outcomes in line with project timelines. ## **Desirable for the role** - Experience in gene therapy, cell therapy, vaccines, biologics or other GMO-containing therapeutic products. - Experience preparing technical sections of DNIR or DIR applications. - Understanding of Australian clinical trial start-up requirements and site governance processes. - Knowledge of drug development and commercial product lifecycle management. - Influencing skills and experience coordinating input from global functional experts. ## **Why AstraZeneca?** At AstraZeneca, we’re dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. We offer an inclusive culture that champions diversity and collaboration, and we are committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. This role offers the chance to join a global biopharmaceutical organisation with a strong brand, a growing pipeline and a focus on frontier science. You’ll be working in a high-growth area, with the opportunity to build deep experience in GMO and OGTR-related regulatory work while also staying connected to broader TGA-related pathways and future opportunities within the Regulatory Affairs team. ## **So, what’s next!** - Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you. - Are you ready to bring new ideas and fresh thinking to the table? Brilliant. We have one seat available and we hope it’s yours. ## **Guidance on AI use** We support you using AI tools responsibly in the recruitment process to help you be at your best and showcase your knowledge, skills and abilities. Review our guide built to assist you in doing this: [AI guidance](https://careers.astrazeneca.com/aiguidance). ## **Where can I find out more?** - Visit our global website: [AstraZeneca Global Website](https://www.astrazeneca.com/) - Follow AstraZeneca on LinkedIn: [AstraZeneca on LinkedIn](https://www.linkedin.com/company/1603/) - Follow us on Instagram: [AstraZeneca on Instagram](https://www.instragram.com/astrazeneca/) AstraZeneca in Australia has been formally recognised as a Silver Tier Employer within the Australian Workplace Equality Index (AWEI). Visit our ANZ Careers Page: [AstraZeneca ANZ Careers](https://www.astrazeneca.com.au/careers.html) to learn more about our commitment to fostering a flexible, diverse and inclusive environment. We recognise that any recruitment process may present challenges. If there is anything we can do to make our recruitment process more accessible for you, please let us know via this [accessibility form](https://forms.office.com/Pages/ResponsePage.aspx?id=o4mOr6zZL0KtBsxOtCFDFDlQbNTPZApBlQh8e2oSY3VUNklNUDhIQk45VkdJTUxVOVNFMjFKMjdXWiQlQCN0PWcu). **Date Posted** 21-Aug-2026 **Closing Date** 20-Sept-2026 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.