Regulatory Affairs Specialist

3 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $80,000 - $120,000

Job Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for supporting regulatory affairs activities for assigned products in Australia and New Zealand.

Main Responsibilities:

  • Support Regulatory Activities: Ensure compliance with all relevant regulations while assisting in developing strategies to facilitate product development, registration, and commercialisation.
  • Manage Regulatory Documentation: Prepare, compile, and submit accurate regulatory documentation for product registrations, variations, renewals, and responses to queries.
  • Liaise with Authorities: Maintain positive relationships with regulatory authorities, monitoring and conveying developments in the regulatory landscape.
  • Collaborate with Teams: Provide regulatory guidance throughout the product lifecycle, represent regulatory affairs in decision-making processes, and assist with commercialisation.

About the Role

This is an exciting opportunity to work within our Clinical, Medical, Regulatory (CMR) Oceania team, reporting directly to the Regulatory Affairs Director. Our department focuses on leading regulatory affairs activities for new products and product amendments, working closely with health authorities and policymakers to shape future regulatory frameworks and ensure the safety and efficacy of our products.

Requirements

  • 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.

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