SeniorRegulatoryAffairsAssociate

We are actively building a talent pipeline for******Senior Regulatory Affairs Associate** positions If you’d like to be among the first to hear about these upcoming roles, we invite you to join our Talent Network. By registering, you’ll gain access to early notifications of vacancies, networking opportunities, and tailored insights to support your career development. Stay connected with us and secure your chance to be part of our future hiring initiatives. At AstraZeneca, we’re driven by the power of science and the promise of transformative medicines. Our Regulatory Affairs team turns scientific innovation into patient impact by securing timely, high‑quality approvals and optimised labels. Join us to shape regulatory outcomes that accelerate access for patients across Australia and beyond. **About the role** As a Senior Regulatory Affairs Associate, you will prepare and execute regulatory submission plans for allocated products and projects, translating agreed regulatory strategies into high‑quality, timely submissions to the TGA (and partnering with NZ where relevant). You’ll provide operational and tactical regulatory input to cross‑functional teams, manage end‑to‑end submissions, and maintain product compliance throughout the lifecycle. Success means balancing scientific rigor with commercial pragmatism to achieve an optimum label and the earliest feasible availability for patients. **What you’ll do** * Lead regulatory project delivery in Australia, providing operational and tactical Regulatory Affairs expertise to meet business milestones and patient access goals * Plan, prepare and manage simple and complex TGA submissions end to end, ensuring quality and on‑time filing * Draft, negotiate and maintain PI and CMI to reflect evolving clinical, safety and CMC data and optimise labels * Coordinate and author responses to TGA questions, managing agency interactions to progress approvals efficiently * Assess and implement lifecycle changes (CMC, CDS, PI), selecting