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.
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