Country Head, Regulatory Affairs, Australia And New Zealand
Moderna Inc
Melbourne, Victoria, Australia
Not specified; not specified; best-in-class health...
15+ years regulatory affairs experience
Tga and medsafe regulatory framework knowledge
Cmc regulatory requirements expertise
This role defines and drives local regulatory strategy in alignment with global priorities to ensure seamless execution from development through lifecycle management
Job Summary
This role defines and drives local regulatory strategy in alignment with global priorities to ensure seamless execution from development through lifecycle management.
The position plays a critical role in supporting Moderna's strategic partnership with the Australian Government to enable local vaccine production and strengthen regional health security.
Moderna offers best-in-class healthcare, family building benefits, generous paid time off, and a holistic approach to well-being including fitness and mental health support.
Matching Summary
This role defines and drives local regulatory strategy in alignment with global priorities to ensure seamless execution from development through lifecycle management.
Salary
Not specified; Not specified; Best-in-class healthcare, family building benefits, generous paid time off, savings and investments
Skills & Requirements
Must-have
15+ years Regulatory Affairs experience
TGA and Medsafe regulatory framework knowledge
CMC regulatory requirements expertise
Global matrix organization leadership
Regulatory submission planning and execution
Nice-to-have
Vaccine and infectious disease therapeutic area experience
AI-driven regulatory tools proficiency
Rare diseases and oncology pipeline knowledge
Strategic partnership development skills
High-performing team building and mentoring
Key Requirements
Advanced degree in Life Sciences (PharmD, MSc, PhD)
Extensive experience in pharmaceutical/biotech regulatory affairs
Demonstrated success leading major regulatory submissions
Strong understanding of CTD global regulatory frameworks