Scientific Regulatory Compliance Professional

7 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $120,000
Regulatory Affairs Specialist

Our organization is seeking a skilled Regulatory Affairs Specialist to support regulatory processes for products in Australia and New Zealand, ensuring compliance while promoting development and registration.

  • Support regulatory activities for assigned products in Australia and New Zealand, ensuring compliance while assisting in developing strategies to facilitate product development, registration, and commercialisation.
  • Manage the preparation, compilation, and timely submission of accurate regulatory documentation for product registrations, variations, renewals, and responses to queries.
  • Liaise 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 management systems, participate in audits to ensure compliance with regulatory standards, and contribute to updating and implementing Standard Operating Procedures (SOPs) as needed.
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 be an Australian Citizen or Permanent Resident.

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