Product Registration Specialist

1 week ago

North Sydney Council, Australia beBeeRegulatory Full time $90,000 - $110,000
Regulatory Affairs Specialist Role

The Regulatory Affairs Specialist is a key member of the Clinical, Medical & Regulatory (CMR) Oceania team responsible for ensuring regulatory compliance and promoting product development and registration in Australia and New Zealand.

Key responsibilities include:

  • Supporting regulatory affairs activities for assigned products, ensuring compliance while developing strategies to facilitate product development, registration, and commercialisation.
  • Preparing, compiling, and submitting accurate regulatory documentation for product registrations, variations, renewals, and responses to queries.
  • Liaising with regulatory authorities, maintaining positive relationships while monitoring and conveying developments in the regulatory landscape.
  • Collaborating 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.
  • Maintaining accurate regulatory records for assigned products in Regulatory Information Management (RIM) platforms, participating in audits to ensure compliance with regulatory standards, and contributing to updating and implementing Standard Operating Procedures (SOPs) as needed.
Your Department

You will be part of the 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.

Required Skills and Qualifications

To succeed in this role, you will need:

  • A Bachelor's degree in a scientific discipline or related field.
  • Minimum 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.

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