Country Head, Regulatory Affairs, Australia And New Zealand
Moderna
Melbourne, Australia
Remote
Define and lead local regulatory strategy
Interface with tga and medsafe
Oversee regulatory submissions and lifecycle
As the senior regulatory leader for Australia and New Zealand, this role defines and drives local regulatory strategy in alignment with global priorities, ensuring seamless execution from development through lifecycle management
Job Summary
As the senior regulatory leader for Australia and New Zealand, this role defines and drives local regulatory strategy in alignment with global priorities, ensuring seamless execution from development through lifecycle management.
This position is central to advancing Moderna’s strategic partnership with the Australian Government, including supporting the establishment and evolution of local mRNA manufacturing capabilities in Melbourne.
Moderna offers best-in-class healthcare, a holistic approach to well-being, family building benefits, and generous paid time off.
Matching Summary
As the senior regulatory leader for Australia and New Zealand, this role defines and drives local regulatory strategy in alignment with global priorities, ensuring seamless execution from development through lifecycle management.
Skills & Requirements
Must-have
Define and lead local regulatory strategy
Interface with TGA and Medsafe
Oversee regulatory submissions and lifecycle
Translate global strategies to local approvals
Lead local regulatory strategy team
Nice-to-have
Advance mRNA science
Strategic partnership with Australian Government
Shape external regulatory environment
Leverage digital innovation and AI tools
Key Requirements
Degree in Life Sciences or related discipline, advanced degree preferred
Extensive experience in Regulatory Affairs (typically 15+ years)
Demonstrated leadership experience
Strong knowledge of Australian (TGA) and New Zealand (Medsafe) regulatory frameworks
Proven experience in defining and executing regulatory strategies across product lifecycle