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.
An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development.
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 throughout lifecycle
draft, negotiate and maintain PI and CMI
assess and implement lifecycle changes
identify regulatory risks and implement mitigations
Nice-to-have
customer focus with ability to prioritise
driving multiple submissions to deadlines
pioneer the future of healthcare
inclusive culture that champions diversity
Key Requirements
University degree in scientific or related discipline