Regulatory Affairs Specialist for New Products and Product Amendments

1 week ago

North Sydney Council, Australia Novo Nordisk AS Full time

We are seeking a highly skilled Regulatory Affairs Specialist to join our Clinical, Medical, Regulatory (CMR) team at Novo Nordisk A/S in Oceania.

The successful candidate will have the opportunity to play a key role in leading regulatory affairs activities for assigned products in Australia and New Zealand, ensuring compliance while developing strategies to assist product development, registration, and commercialisation.

About the Department

  • This position involves managing 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.

Estimated Salary: AU$80,000 - AU$110,000 per annum, depending on experience

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