About the job
The Country Head, Regulatory Affairs for Australia and New Zealand is a pivotal job based in Melbourne, responsible for shaping and executing local regulatory strategies in harmony with global objectives. This position plays a crucial role in ensuring successful local approvals and compliance, while also fostering innovative partnerships and local manufacturing capabilities. The team thrives on collaboration and strategic thinking, aiming to make a meaningful impact on public health.
You'll be responsible for
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Defining and leading local regulatory strategy
Define and lead local regulatory strategy across Australia and New Zealand, ensuring alignment with global regulatory strategies while driving optimal local outcomes.⚖️
Providing regulatory leadership
Provide regulatory leadership for interactions with TGA and Medsafe, including high-impact engagements, scientific advice, and negotiation of regulatory pathways.📅
Overseeing regulatory submissions
Oversee the planning, preparation, and execution of regulatory submissions and lifecycle activities, ensuring quality, compliance, and timely delivery across development and marketed products.Key criteria
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Degree in life sciences or related discipline
Possession of a relevant degree, advanced degree preferred.View
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15+ years in regulatory affairs
Extensive experience in pharmaceutical/biotech regulatory strategy.View
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Knowledge of TGA and Medsafe frameworks
Strong understanding of Australian and New Zealand regulatory requirements.View
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