Regulatory Compliance Specialist

6 hours ago

Sydney, New South Wales, Australia beBeeCompliance Full time $90,000 - $123,456
Regulatory Compliance Specialist

Are you passionate about ensuring the safety and compliance of life-changing products?

  • Support regulatory activities for assigned products in Australia and New Zealand, maintaining compliance while developing strategies to facilitate product development, registration, and commercialization.
  • Manage the preparation, compilation, and timely submission of accurate regulatory documentation for product registrations, variations, renewals, and responses to queries.
  • Liaise with regulatory authorities, building 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 commercialization.
  • 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.

As a key member of our Clinical, Medical, Regulatory (CMR) Oceania team, you will report directly to the Regulatory Affairs Director. Our department focuses on leading regulatory affairs activities for new products and product amendments. We work closely with health authorities and policymakers to shape future regulatory frameworks and ensure the safety and efficacy of our products.

The atmosphere is collaborative and dynamic, with a strong focus on professional development and continuous improvement. Based in Sydney, you'll join a team that values innovation, teamwork, and making a meaningful impact on patients' lives.

Key Skills and Qualifications:
  • Strong understanding of regulatory compliance principles and regulations.
  • Excellent communication and collaboration skills.
  • Able to work independently and as part of a team.
  • Proven analytical and problem-solving skills.
  • Ability to maintain confidentiality and handle sensitive information.
Benefits:
  • Opportunity to work with a dynamic and innovative team.
  • Professional development and growth opportunities.
  • Collaborative and supportive work environment.

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