Regulatory Affairs Manager ANZ

About the role

The Regulatory Affairs Manager ANZ leads the regulatory function for Australia and New Zealand, overseeing registration, maintenance and compliance of Clinigen's product portfolio. The role combines scientific, regulatory and commercial expertise to develop strategies that support business objectives while ensuring compliance with TGA and Medsafe requirements.

Key responsibilities

• Lead, coach and develop the ANZ Regulatory Affairs team, managing priorities and resource utilisation.
• Develop and execute regulatory strategies, identify risks and opportunities, and provide input to commercial and portfolio planning.
• Oversee preparation, review and submission of applications to the TGA and Medsafe, ensuring timely approvals and lifecycle management.
• Provide strategic input to business development, product acquisitions/divestments and portfolio expansion.
• Ensure regulatory activities comply with legislation, maintain inspection readiness and support audits.
• Collaborate with Commercial, Medical Affairs, Quality, Supply Chain and other functions to deliver compliant product launches and initiatives.

Required profile

• Bachelor's degree in Pharmacy, Life Sciences, Biomedical Science or related discipline.
• 8‑10 years of pharmaceutical regulatory affairs experience covering Australia and New Zealand.
• Proven leadership experience managing and mentoring regulatory professionals.
• Strong strategic thinking with ability to assess regulatory risks and commercial implications.
• Excellent communication, stakeholder management and negotiation skills.

Required skills

• In‑depth knowledge of TGA and Medsafe regulatory requirements.
• Experience managing end‑to‑end regulatory submissions across the product lifecycle.
• Project management and organisational prioritisation abilities.
• Ability to analyse and communicate complex scientific and regulatory information.