Regulatory Affairs Manager

vor 1 Monat

Sydney, Österreich Healthcare Professionals Group Vollzeit

Benefits
• Career development in Regulatory Affairs
• Opportunity to lead a Regulatory portfolio across ANZ
• Work with a global leader in healthcare
• Flexible work-life balance

About the Company
Our client is a global leader in healthcare, specialising in a diverse range of health products including medical devices, nutrition, and pharmaceuticals.
With operations in over 160 countries, they are dedicated to improving health outcomes across all life stages.

About the Opportunity
This role is responsible for leading a specific portfolio for the Regulatory Affairs function across ANZ.
You will develop regulatory strategies, manage submissions to ensure product approvals, and provide high-level regulatory advice to internal and external stakeholders.
The role is key in maintaining and expanding our client's portfolio in compliance with all regional regulations, supporting product innovation and lifecycle management.
You will report to senior leadership and work collaboratively with cross-functional teams.

Duties Lead and provide strategic direction for ANZ regulatory submissionsOversee lifecycle management activities, including labelling, change control, and promotional material reviewDevelop regulatory strategies for product registration and manage complementary medicine/drug submissionsLiaise with regulatory authorities and negotiate for product approvalsMonitor external regulatory changes and assess their business impactRepresent our client at international and local regulatory conferences Skills and Experience
• Science Degree or equivalent
• Experience working in Regulatory Affairs, preferably in nutrition or FMCG
• Experience with FSANZ, MedSafe, TGA, and other authorities
• Strong project management and communication skills

Culture
Our client fosters an inclusive, diverse culture that values innovation, collaboration, and professional development.
Employees are empowered to achieve a healthy work-life balance while contributing to global healthcare solutions.

How to Apply
Click apply or contact Gemma Staddon, Specialist Manager on ****** for a confidential discussion.
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