Regulatory Affairs Associate

4 weeks ago

North Sydney Council, Australia Novo Nordisk Full time
Overview

Regulatory Affairs Associate role at Novo Nordisk, Sydney, Australia. 12-month contract within the Clinical, Medical & Regulatory (CMR) Oceania team. Ready to make an impact? Read on to learn more.

Your new role

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 in 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.
  • Collaborate 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 implementing Standard Operating Procedures (SOPs) as needed.
Your department

You will be part of the Clinical, Medical, Regulatory (CMR) Oceania team, reporting to the Regulatory Affairs Director. The department leads regulatory affairs activities for new products and product amendments, working with health authorities to shape regulatory frameworks and ensure safety and efficacy of products. The environment is collaborative and focused on professional development and continuous improvement. Based in Sydney, you'll join a team that values innovation, teamwork, and meaningful patient impact.

Your Skills and Qualifications

We're looking for an experienced Regulatory Affairs Associate who can thrive in a high-paced, dynamic environment. You'll bring:

  • Bachelor\'s degree in a scientific discipline or 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 be an Australian Citizen or Permanent Resident.
Working at Novo Nordisk

We pursue solutions that defeat serious chronic diseases with an unconventional spirit, determination, and curiosity. For over 100 years, we have built a company focused on purpose, respect, and going beyond what we know to deliver extraordinary results.

Deadline

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

Note: Novo Nordisk is a pharmaceutical company focused on long-term health and patient outcomes. We seek new ideas and place people first as we push the boundaries of science.


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