Senior Regulatory Affairs Associate

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 appropriate regulatory pathways to maintain compliance
• Identify regulatory risks and implement mitigations to protect labels, timelines and supply continuity
• Collaborate with global Regulatory Affairs and local stakeholders (Quality, Supply Chain, Medical, Safety, Commercial) for aligned delivery
• Operate to GRP, GMDP and AZ GxP QMS standards; complete training and drive continuous compliance improvement
• Work in line with the AZ Code of Ethics and OH&S policies to maintain a safe, inclusive, high‑integrity environment
  
  

Essential Skills And Experience

• University degree in a scientific or related discipline.
• Experience in Regulatory Affairs within the pharmaceutical industry or experience at a health authority.
• Strong knowledge of the drug development process and post‑approval lifecycle management.
• Excellent written and verbal communication; confident drafting/negotiating PI/CMI content.
• Analytical and critical thinking with delivery and results orientation.
• Proven cross‑functional collaboration and stakeholder management.
• Customer focus with the ability to prioritise and drive multiple submissions to deadlines.
  
  

Desirable

• Broader pharmaceutical experience (e.g., Quality Control, Clinical Trial Management).
• Demonstrated leadership of cross‑functional projects or teams.
• Influencing skills with a track record of shaping regulatory outcomes.
  
  

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. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

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.
  
  

Where can I find out more?

• Visit our Global Website - https://www.astrazeneca.com/
• Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
• Follow us on Instagram – https://www.instragram.com/astrazeneca/
  
  

AstraZeneca in Australia has been formally recognised as an Employer of Choice for Gender Equality by the Workplace Gender Equality Agency (WGEA) and as a Gold Tier Employer within the Australian Workplace Equality Index (AWEI). Visit our ANZ Careers Page - 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 Form.

Date Posted

24-Mar-2026

Closing Date

23-Apr-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.

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