Regulatory Affairs Director

4 days ago

Sydney, New South Wales, Australia Healthcare Professionals Group Full time

About the Role

This is a key position within our client's Regulatory Affairs function, responsible for leading a specific portfolio across ANZ. The successful candidate will develop regulatory strategies, manage submissions to ensure product approvals, and provide high-level regulatory advice to internal and external stakeholders.

Key Responsibilities

• Develop and implement regulatory strategies for product registration and lifecycle management

• Oversee the preparation and submission of regulatory documents to authorities such as FSANZ, MedSafe, and TGA

• Collaborate with cross-functional teams to ensure compliance with regional regulations and industry standards

• Provide regulatory guidance and support to internal stakeholders, including product development and commercial teams

• Stay up-to-date with external regulatory changes and assess their impact on the business

• Represent our client at international and local regulatory conferences and meetings

Requirements

• Science degree or equivalent

• Proven experience working in Regulatory Affairs, preferably in the healthcare or FMCG industry

• Strong knowledge of regulatory authorities and industry standards in ANZ

• Excellent project management and communication skills

About Our Client

Our client is a global leader in healthcare, dedicated to improving health outcomes across all life stages. They foster an inclusive, diverse culture that values innovation, collaboration, and professional development.

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