Regulatory Affairs Professional

6 days ago

North Sydney Council, Australia Novo Nordisk AS Full time

About the Role
Novo Nordisk A/S is seeking a highly skilled Senior Regulatory Affairs Associate to join our Clinical, Medical, Regulatory (CMR) Oceania team. As a key member of the team, you will be responsible for leading regulatory affairs activities for assigned products in Australia and New Zealand.

Key Responsibilities
• Lead regulatory affairs strategies for assigned products, ensuring compliance with Australian regulatory requirements.
• Manage the preparation, compilation, and timely submission of accurate regulatory documentation for new product registrations, variations, renewals, and responses to queries.
• Serve as the primary liaison with regulatory authorities, maintaining positive relationships and monitoring regulatory developments.
• Collaborate with cross-functional teams to provide regulatory guidance throughout the product lifecycle and assist with commercialisation.
• Maintain accurate regulatory records and participate in audits to ensure compliance with regulatory standards.

Requirements
• Bachelor's degree in a scientific discipline or a related field.
• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or healthcare industry, with significant expertise in Australian regulatory requirements.
• Strong competency in stakeholder management, business acumen, and regulatory affairs intelligence.

About Us
Novo Nordisk A/S is a global healthcare company with a strong focus on diabetes and obesity care. We are committed to delivering life-changing medicines that improve the lives of people around the world.

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