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).
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.
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
Provide operational and tactical regulatory input
Manage end-to-end submissions
Maintain product compliance throughout lifecycle
Draft, negotiate and maintain PI and CMI
Coordinate and author responses to TGA questions
Operate to GRP, GMDP and AZ GxP QMS standards
Nice-to-have
Scientific rigor with commercial pragmatism
Collaborate with global Regulatory Affairs
Drive continuous compliance improvement
Shape regulatory outcomes
Pioneer the future of healthcare
Key Requirements
University degree in a scientific or related discipline
Experience in Regulatory Affairs within the pharmaceutical industry or at a health authority
Strong knowledge of drug development and lifecycle management
Excellent written and verbal communication skills
Analytical and critical thinking
Proven cross-functional collaboration and stakeholder management
Customer focus with ability to prioritize multiple submissions