Health and Aged Care Professionals – Melbourne VIC
Full time
3mo ago , from Health and Aged Care Professionals
Once-in-a-career regulatory leadership opportunity
Pioneer the regulatory landscape for innovative medicines in Australia
Market-leading remuneration including substantial equity on appointment
About the company
Healthcare Professionals Group is proud to partner with one of the pharmaceutical sector's most dynamic and transformational organisations - a company that has played a pivotal role in saving lives and improving health outcomes for patients globally.
With an expanding pipeline, this organisation has genuinely exciting and ambitious plans for Australia and the region.
This is a company where you don't follow the regulatory guideline, you help build it.
Where the work you do will shape how Australia's health authorities approach an entirely new class of medicines.
And where being part of a lean, high-calibre team means extraordinary breadth of exposure and genuine impact.
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 be operating at the intersection of strategic leadership, health authority engagement, and one of the most exciting manufacturing stories in Australian healthcare.
This is not a standard affiliate regulatory head role.
Melbourne is home to this organisation's manufacturing facility, a significant and ongoing regulatory responsibility that sets this position apart from a typical ANZ affiliate regulatory head.
You will play a central role in the regulatory oversight of that facility, including site licensure, GMP compliance and lifecycle management, as the organisation continues to develop its local manufacturing capability with a view to supplying the 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 - negotiating with credibility, engaging as a genuine partner, and knowing when to push and when to give - will be central to your success.
You will lead a small, capable internal team and a well-established network of specialist external vendors, providing the senior regulatory direction and strategic positioning the team needs to operate at its best.
You will also sit on the ANZ leadership team and represent Australia and New Zealand in global regulatory forums.
Reporting to the regional regulatory head, and working closely with the ANZ General Manager, this is a role with genuine global visibility and local accountability.
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 negotiation of 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 setting through engagement with health authorities, industry associations and policy forums, particularly 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 demonstrated 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 sufficient 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
The 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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📌 Country Head, Regulatory Affairs, Anz (Melbourne)
🏢 Health and Aged Care Professionals
📍 Melbourne