About the opportunity
As the senior regulatory leader for Australia and New Zealand, you will define and drive local regulatory strategy in alignment with global priorities. You'll operate at the intersection of strategic leadership, health authority engagement, and an exciting manufacturing story in Australian healthcare.
This role is unique compared to typical affiliate regulatory heads because it includes regulatory oversight of the organisation's Melbourne manufacturing facility, covering site licensure, GMP compliance, and lifecycle management as the company expands local manufacturing capabilities for Australian and export markets.
You will serve as the primary interface with the Therapeutic Goods Administration and Medsafe, leading high‐impact negotiations, scientific advice discussions, and the shaping of regulatory pathways for innovative platforms. Your ability to build and maintain senior relationships with health authorities will be central to your success.
Your responsibilities also include leading a small internal team and managing a network of specialist external vendors, providing strategic direction to the team and operationalising regulatory priorities. You will sit on the ANZ leadership team, represent ANZ in global regulatory forums, and work closely with the ANZ General Manager.
Key responsibilities
* Define and lead ANZ regulatory strategy across the product lifecycle, ensuring alignment with global priorities and optimal local outcomes.
* Serve as primary interface with TGA and Medsafe – leading high‐impact engagements, scientific advice discussions and negotiating regulatory pathways.
* Provide regulatory leadership and strategic oversight for the Melbourne manufacturing facility, including site licensure, GMP inspection readiness and ongoing lifecycle management.
* Oversee planning, preparation and execution of regulatory submissions and lifecycle activities across development and marketed products.
* Contribute to shaping the external regulatory environment through engagement with health authorities, industry associations and policy forums, advancing frameworks for innovative biopharmaceutical platforms.
* Provide regulatory input to support local research and clinical collaborations.
* Lead, develop and direct the local regulatory team and external vendor network.
* Represent ANZ in global regulatory and cross‐functional forums, advocating for regional needs and influencing global decision‐making.
* Partner with the ANZ GM and cross‐functional teams including Clinical, Quality, Manufacturing, Medical and Commercial to support product development and launch.
* Identify, assess and proactively manage regulatory risks, aligning strategies with business objectives.
Skills & experience
* Degree in Life Sciences or related discipline; advanced degree preferred (PharmD, MSc, PhD or equivalent).
* Extensive regulatory affairs experience within pharma, with significant time in regulatory strategy.
* Demonstrated senior leadership experience, including building, leading and developing high‐performing regulatory teams.
* Strong knowledge of TGA regulatory frameworks and proven success in senior TGA engagement and negotiation.
* Proven track record leading major regulatory submissions and high‐impact health authority interactions.
* Experience with global regulatory frameworks (e.g., CTD) and their application across regions.
* Familiarity with CMC regulatory requirements to engage credibly with technical experts and health authorities on manufacturing, quality and inspection matters.
* Proven ability to operate in a global, matrixed organisation, influencing cross‐functional teams and senior stakeholders.
* Ability and appetite to operate as both a strategic leader and a hands‐on contributor in a lean team environment.
* Exposure to regulatory policy engagement and shaping of novel regulatory frameworks (preferred, not essential).
Benefits
* Market‐leading remuneration package including base salary, performance bonus and substantial new hire and annual equity.
* Comprehensive health and wellbeing benefits.
* Life and disability insurance.
* Access to global teams, world‐class science and a pipeline that is genuinely changing medicine.
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