Senior Regulatory Affairs Associate

AstraZeneca

Australia, Australia
Prepare and execute regulatory submission plans
Operational and tactical regulatory input
Manage end-to-end submissions
Join us to shape regulatory outcomes that accelerate access for patients across Australia and beyond

Job Summary

  • Join us to shape regulatory outcomes that accelerate access for patients across Australia and beyond.
  • 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

Join us to shape regulatory outcomes that accelerate access for patients across Australia and beyond.

Skills & Requirements

Must-have

  • prepare and execute regulatory submission plans
  • operational and tactical regulatory input
  • manage end-to-end submissions
  • maintain product compliance
  • draft, negotiate and maintain PI and CMI
  • assess and implement lifecycle changes

Nice-to-have

  • pioneer the future of healthcare
  • inclusive culture that champions diversity
  • lifelong learning, growth and development
  • entrepreneurial spirit

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

Work Rights

Not specified

Tailored Resume

Cover Letter