Regulatory Affairs Specialist

2 months ago

North Sydney Council, Australia Novo Nordisk AS Full time

Are you passionate about regulatory affairs and eager to contribute to the development of life-changing medicines? We invite you to explore a career opportunity as a Senior Regulatory Affairs Associate at Novo Nordisk Oceania.

About the Department

You will be part of the Clinical, Medical, Regulatory (CMR) Oceania team, reporting directly to the Senior Regulatory Affairs Manager. 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 Position

As a Senior Regulatory Affairs Associate, you will:

  • Lead regulatory affairs activities for assigned products in Australia and New Zealand, ensuring compliance while developing strategies to assist 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 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 implementation of Standard Operating Procedures (SOPs) as needed.

Qualifications

  • 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.

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