Director - Regulatory Affairs

Healthcare Professionals Group; Melbourne; Ibrido; AUD 180.000 - 240.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Leadership

Regulatory affairs

Stakeholder management

Cross-functional collaboration

Biologics

Australian regulatory environment

Strategic thinking

Formazione

Bachelor's degree in a relevant scientific discipline

Descrizione del lavoro

About the Role

We are partnering with an established global biopharmaceutical organisation to appoint a Director, Regulatory Affairs for Australia and New Zealand. Based in Melbourne, this role sits within the company's Global Regulatory Affairs function and forms part of a broader regional team. This is a newly created leadership position offering a clear step-up to a regional remit. You will lead the local regulatory team, act as the primary external interface with local health authorities and industry bodies, and shape regulatory strategy across a diverse specialty portfolio.

Key Responsibilities

• Lead and develop the local regulatory team, supporting day-to-day decision-making and acting as the first point of escalation.
• Build and grow a high-performing team, attracting talent and developing capability across the function.
• Serve as the primary interface with relevant health authorities, government bodies and industry associations.
• Develop and execute innovative regulatory strategies for new product registrations, lifecycle management and launches.
• Ensure strict compliance with local regulations, leading audit and inspection readiness.
• Partner closely with Commercial Operations, Medical and other cross-functional stakeholders to translate regulatory insight into actionable business plans.
• Provide expert review of promotional materials, labelling and product information in line with local legislation.
• Represent the organisation in industry forums and policy activities, sharing insights and best practice.

About You

• 10+ years of regulatory affairs experience in the pharmaceutical or biotech industry, including significant time in a health-authority-facing role.
• Demonstrated leadership experience, including building and managing high-performing teams.
• In-depth knowledge of the Australian regulatory environment; New Zealand exposure highly regarded.
• Specialty biologics experience well regarded.
• Strong commercial acumen and a track record of working cross-functionally with Medical, Commercial and Pharmacovigilance teams.
• Excellent stakeholder management skills and the ability to influence at all levels in a complex, global matrix environment.
• Bachelor's degree in a relevant scientific discipline

What's on Offer

• Hybrid working arrangement based out of Melbourne.
• The opportunity to shape regulatory strategy for a globally significant portfolio.
• Genuine regional career progression within a respected regional team