Regulatory Affairs Associate

Regulatory Affairs Associate
Clinical, Medical & Regulatory (CMR)
Sydney, Australia

As a Regulatory Affairs Associate, you will support regulatory processes for products in Australia and New Zealand, ensuring compliance while promoting development and registration. Your role involves managing document submissions, engaging with regulatory authorities, and maintaining regulatory records. Your key responsibilities include:

• Support regulatory affairs activities for assigned products in Australia and New Zealand, ensuring compliance while assisting developing strategies to facilitate product development, registration, and commercialisation.
• Manage the preparation, compilation, and timely submission of accurate regulatory documentation for product registrations, variations, renewals, and responses to queries.
• Liaise with regulatory authorities, maintaining positive relationships while monitoring and conveying developments in the regulatory landscape.
• Support with collaboration with cross-functional teams and stakeholders to provide regulatory guidance throughout the product lifecycle, represent regulatory affairs in decision-making processes, and assist with commercialisation.
• Maintain accurate regulatory records for assigned products in Regulatory Information Management (RIM) platforms, participate in audits to ensure compliance with regulatory standards, and contribute to updating and implementation of Standard Operating Procedures (SOPs) as needed.

You will be part of the Clinical, Medical, Regulatory (CMR) Oceania team, reporting directly to the Regulatory Affairs Director. Our department is focused on leading regulatory affairs activities for new products and product amendments. We work closely with health authorities and policymakers to shape future regulatory frameworks and ensure the safety and efficacy of our products.

The atmosphere is collaborative and dynamic, with a strong focus on professional development and continuous improvement. Based in Sydney, you'll join a team that values innovation, teamwork, and making a meaningful impact on patients\' lives.

We're looking for an experienced Regulatory Affairs Associate who will appreciate working in a high-paced, dynamic environment. You'll bring with you:

• Bachelor\'s degree in a scientific discipline or a related field.
• A minimum of 2 years of experience in regulatory affairs within the pharmaceutical industry.
• Knowledge of Australian regulatory requirements.
• Demonstrated proficiency in supporting the preparation and submission of regulatory documentation, as well as the development and approval of product labeling.
• Must either be an Australian Citizen or Permanent Resident.

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.

4 October 2025. Applications are reviewed on an ongoing basis.

Novo Nordisk is not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.