ANZ Regulatory Affairs Leader

Health and Aged Care Professionals; Sydney; On-site; AUD 180,000 - 240,000; Full time

Benefits offered by this job

Leadership role

Team leadership

Regulatory exposure

Career growth

Job summary

Health and Aged Care Professionals in Sydney seeks an experienced Regulatory Affairs leader to oversee ANZ regulatory strategy and execution. Leading a small team, you will shape registration pathways, lifecycle activities and strategic opportunities across Australia and New Zealand.

You will work closely with senior leadership, Commercial, Quality and external partners to deliver submissions, risk assessments and timelines, while staying hands-on with technical guidance and regulatory advice.

Qualifications

• 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.

Responsibilities

• 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

Regulatory affairs

TGA

Medsafe

Regulatory strategy

Stakeholder management

People leadership

Job description

Health and Aged Care Professionals in Sydney seeks an experienced Regulatory Affairs leader to oversee ANZ regulatory strategy and execution. Leading a small team, you will shape registration pathways, lifecycle activities and strategic opportunities across Australia and New Zealand.

You will work closely with senior leadership, Commercial, Quality and external partners to deliver submissions, risk assessments and timelines, while staying hands-on with technical guidance and regulatory advice.