ANZ Regulatory Affairs Leader: Strategy & Lifecycle

Clinigen Group; Sydney; On-site; AUD 130,000 - 190,000; Full time

Job summary

Clinigen Group in Australia and New Zealand seeks a Regulatory Affairs Manager ANZ to lead regulatory strategy, registration and lifecycle management across the portfolio. You will collaborate with commercial, quality, and partners to ensure timely approvals and ongoing compliance.

The role requires deep knowledge of TGA and Medsafe requirements, strong leadership, and the ability to drive regulatory programs across a complex product suite while balancing business objectives.

Qualifications

• Bachelor’s degree in Pharmacy or related life sciences field.
• 8–10 years in pharmaceutical regulatory affairs, ANZ experience preferred.
• Deep knowledge of TGA and Medsafe requirements.
• Proven track record leading regulatory professionals.

Responsibilities

• Lead ANZ regulatory strategy for Australia and New Zealand.
• Oversee registration, variations, renewals and lifecycle activities.
• Partner with Commercial, Quality and Supply Chain to enable market access.
• Manage regulatory submissions to TGA and Medsafe and track commitments.

Skills

Regulatory leadership

Stakeholder management

Strategic thinking

Regulatory submissions

Project management

Life-cycle management

Education

Bachelor’s degree in Pharmacy

Life Sciences background

Job description

Clinigen Group in Australia and New Zealand seeks a Regulatory Affairs Manager ANZ to lead regulatory strategy, registration and lifecycle management across the portfolio. You will collaborate with commercial, quality, and partners to ensure timely approvals and ongoing compliance.

The role requires deep knowledge of TGA and Medsafe requirements, strong leadership, and the ability to drive regulatory programs across a complex product suite while balancing business objectives.