The role involves leading regulatory project delivery in Australia to meet business milestones and patient access goals
Job Summary
The role involves leading regulatory project delivery in Australia to meet business milestones and patient access goals.
Candidates will manage end-to-end submissions to the TGA, including drafting and negotiating Product Information (PI) and Consumer Medicine Information (CMI).
AstraZeneca offers an inclusive culture that champions diversity and is committed to lifelong learning and growth.
Matching Summary
The role involves leading regulatory project delivery in Australia to meet business milestones and patient access goals.
Skills & Requirements
Must-have
TGA submission management
PI and CMI drafting
Cross-functional collaboration
Drug development process knowledge
Lifecycle change implementation
Nice-to-have
Leadership of cross-functional projects
Quality Control experience
Clinical Trial Management background
Influencing regulatory outcomes
Entrepreneurial spirit
Key Requirements
University degree in scientific discipline
Experience in Regulatory Affairs within pharma industry
Strong knowledge of post-approval lifecycle management