Director, Regulatory Affairs — ANZ (Hybrid)

Healthcare Professionals Group; Melbourne; Hybrid; AUD 180,000 - 240,000; Full time

Job summary

Healthcare Professionals Group partners with a global biopharmaceutical organisation to appoint a Director, Regulatory Affairs for Australia and New Zealand. Based in Melbourne, you will lead the local regulatory team, interface with health authorities, and shape regulatory strategy across a diverse portfolio.

You will guide registrations, lifecycle management and launches, drive compliance, and collaborate with Medical, Commercial and Pharmacovigilance teams to enable business growth.

Qualifications

• 10+ years of regulatory affairs experience in the pharmaceutical or biotech industry.
• Significant health-authority-facing leadership experience.
• Strong knowledge of Australian regulatory requirements; NZ exposure valued.

Responsibilities

• Lead the local regulatory team and act as escalation point.
• Interface with health authorities and industry bodies.
• Develop and execute regulatory strategies for registrations and lifecycle management.
• Ensure audit and inspection readiness and regulatory compliance.
• Coordinate with Commercial Operations, Medical and Pharmacovigilance.
• Review promotional materials and product labeling per local laws.

Skills

Leadership

Regulatory affairs

Stakeholder management

Cross-functional collaboration

Biologics

Australian regulatory environment

Strategic thinking

Education

Bachelor's degree in a relevant scientific discipline

Job description

Healthcare Professionals Group partners with a global biopharmaceutical organisation to appoint a Director, Regulatory Affairs for Australia and New Zealand. Based in Melbourne, you will lead the local regulatory team, interface with health authorities, and shape regulatory strategy across a diverse portfolio.

You will guide registrations, lifecycle management and launches, drive compliance, and collaborate with Medical, Commercial and Pharmacovigilance teams to enable business growth.