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)
Job Summary
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).
Success means balancing scientific rigor with commercial pragmatism to achieve an optimum label and the earliest feasible availability for patients.
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.
Matching Summary
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).
Skills & Requirements
Must-have
prepare and execute regulatory submission plans
manage end-to-end submissions
maintain product compliance
draft, negotiate and maintain PI and CMI
coordinate and author responses to TGA questions
assess and implement lifecycle changes
Nice-to-have
entrepreneurial spirit
inclusive culture that champions diversity
lifelong learning, growth and development
pioneer the future of healthcare
Key Requirements
University degree in a scientific or related discipline
Experience in Regulatory Affairs within the pharmaceutical industry
Experience at a health authority
Strong knowledge of the drug development process
Proven cross‑functional collaboration and stakeholder management