Benefits
ANZ leadership role with genuine strategic influence
Lead and develop an established Regulatory Affairs team
Broad exposure across new registrations, lifecycle management and portfolio growth
Join a growing healthcare business with an expanding portfolio and pipeline
About the company
This established healthcare organisation operates across Australia and New Zealand, partnering with a broad range of products and businesses across the pharmaceutical sector.
With continued growth across the region, the business offers a fast-moving and commercially focused environment where Regulatory Affairs plays an important role in portfolio strategy, new opportunities and successful product launches.
About the chance
An exciting opportunity has become available for an experienced Regulatory Affairs leader to take responsibility for the ANZ regulatory function.
Leading a small team, you will oversee regulatory strategy and execution across Australia and New Zealand while remaining close to key submissions, new registrations and complex regulatory projects.
This is broader than a traditional Regulatory Affairs management position.
You will work closely with senior leadership, commercial teams and external partners to assess new opportunities, shape regulatory strategy and provide guidance around pathways, timelines, risk and feasibility.
The role would suit someone who enjoys leading people but still wants to remain connected to the technical and strategic side of Regulatory Affairs.
Duties
Lead, coach and develop the Regulatory Affairs team
Set priorities and oversee regulatory workload across the portfolio
Develop regulatory strategies for new product registrations and lifecycle activities
Provide oversight of submissions to the TGA and Medsafe
Support new registrations, variations,



transfers and post-approval activities
Lead complex or business-critical regulatory projects
Provide regulatory input into new product opportunities, portfolio expansion and business cases
Assess regulatory pathways, timelines, risks and resource requirements for prospective opportunities
Partner with Commercial, Medical Affairs, Quality, Pharmacovigilance, Supply Chain and Business Development
Build strong relationships with external partners and provide strategic regulatory advice
Support regulatory aspects of product launches, manufacturing changes and artwork updates
Contribute to regulatory process improvement, compliance and inspection readiness
Monitor team resources, project requirements and regulatory service delivery
Contribute to broader ANZ leadership discussions and business planning
Skills and Experience
Extensive pharmaceutical Regulatory Affairs experience across the Australian market
Strong knowledge of TGA regulatory requirements and ideally experience across New Zealand/Medsafe
Demonstrated experience managing new registrations as well as ongoing lifecycle activities
Previous people leadership experience, including coaching and developing regulatory professionals
Comfortable remaining hands-on and providing technical guidance when required
Strong understanding of regulatory strategy and the commercial implications of regulatory decisions
Strong stakeholder management skills with the confidence to work with senior internal and external stakeholders
Able to manage multiple priorities within a changing and commercially focused environment
Proactive, solutions-focused and comfortable taking ownership
Culture
Join a collaborative and agile environment where Regulatory Affairs has robust visibility across the wider business.
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📌 Regulatory Affairs Manager (Sydney)
🏢 Healthcare Professionals Group
📍 Sydney