ANZ Regulatory Affairs Leader

Clinigen; Sydney; On-site; AUD 150,000 - 190,000; Full time

Job summary

Clinigen is seeking an experienced Regulatory Affairs Manager ANZ to lead the regulatory function for Australia and New Zealand. You will oversee registrations, lifecycle management and ensure compliance while partnering with internal and external stakeholders to drive market access.

You will manage a capable ANZ regulatory team, develop strategic regulatory plans, and provide expert guidance on complex regulatory submissions and partner engagements.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences or related scientific discipline; 8–10 years in pharmaceutical regulatory affairs.

Responsibilities

• Lead and develop the ANZ Regulatory Affairs team.
• Develop and execute regulatory strategies for timely registrations and lifecycle management.
• Oversee preparation and submission of regulatory filings to TGA and Medsafe.
• Provide strategic input to business development, portfolio planning and market access.
• Ensure compliance, quality systems and post‑approval obligations are tracked and fulfilled.
• Collaborate cross‑functionally with Commercial, Quality, Supply Chain and PV teams.

Skills

Regulatory leadership

Team management

Strategic thinking

Regulatory strategy

Stakeholder management

Project management

Communication

Negotiation

Regulatory submissions

Education

Bachelor's degree in Pharmacy, Life Sciences, Biomedical Science or related discipline

Job description

Clinigen is seeking an experienced Regulatory Affairs Manager ANZ to lead the regulatory function for Australia and New Zealand. You will oversee registrations, lifecycle management and ensure compliance while partnering with internal and external stakeholders to drive market access.

You will manage a capable ANZ regulatory team, develop strategic regulatory plans, and provide expert guidance on complex regulatory submissions and partner engagements.