Product Compliance Specialist

2 weeks ago

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

Clinical, Medical & Regulatory (CMR)

Your new role:

  • Support regulatory processes for products in Australia and New Zealand, ensuring compliance while promoting development and registration.
  • Manage document submissions, engage with regulatory authorities, and maintain regulatory records.

Key responsibilities:

  • Support regulatory affairs activities for assigned products in Australia and New Zealand, ensuring compliance while assisting 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.
  • Support collaboration 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.

About your team:

  • You will be part of the Clinical, Medical, Regulatory (CMR) Oceania team, reporting directly to the Regulatory Affairs Director.
  • The atmosphere is collaborative and dynamic, with a strong focus on professional development and continuous improvement.

We are looking for:

  • An experienced Regulatory Affairs Associate who will appreciate working in a high-paced, dynamic environment.
  • 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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