Senior Regulatory Affairs Specialist

5 days ago

North Sydney Council, Australia Novo Nordisk Full time
About the Role

We are seeking a highly skilled Senior Regulatory Affairs Associate to join our Clinical, Medical, Regulatory (CMR) Oceania team at Novo Nordisk Oceania. As a key member of our team, you will play a critical role in ensuring the availability of life-changing medicines in Australia and New Zealand.

Key Responsibilities
  • Lead regulatory affairs activities for assigned products, ensuring compliance with regulatory requirements and developing strategies to support product development, registration, and commercialisation.
  • 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 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 implementation of Standard Operating Procedures (SOPs) as needed.
Requirements
  • Bachelor's degree in a scientific discipline or a related field.
  • A minimum of 5 years of experience in regulatory affairs within the pharmaceutical or healthcare industry, with significant expertise in Australian regulatory requirements.
  • Demonstrated proficiency in leading regulatory affairs strategies, preparation and submission of regulatory documentation, regulatory affairs intelligence, and the development and approval of product labelling.
  • Strong competency in stakeholder management, comprehensive business and industry knowledge, adaptability in dynamic environments, effective execution, and impactful communication.
  • Must either be an Australian Citizen or Permanent Resident.
About Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We're inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why we're all here - to ensure that people can lead a life independent of chronic disease.

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