Senior Regulatory Affairs Associate

AstraZeneca

Australia
Regulatory submission plans
Tga submissions
Product lifecycle management
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.

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

  • Regulatory submission plans
  • TGA submissions
  • Product lifecycle management
  • Cross-functional collaboration
  • Maintain product compliance

Nice-to-have

  • Scientific rigor
  • Commercial pragmatism
  • Entrepreneurial spirit
  • Lifelong learning
  • Shaping regulatory outcomes

Key Requirements

  • University degree in scientific discipline
  • Experience in Regulatory Affairs
  • Experience at health authority
  • Strong knowledge drug development process
  • Analytical and critical thinking skills
  • Customer focus and prioritization skills

Work Rights

Not specified

Tailored Resume

Cover Letter