Regulatory Compliance Specialist

2 days ago

North Sydney Council, Australia beBeeRegulatory Full time $99,691 - $121,668
Regulatory Affairs Professional

The Regulatory Affairs Associate role involves supporting regulatory processes for products in Australia and New Zealand.

Key Responsibilities:
  • Ensure compliance while assisting in developing strategies to facilitate product development, registration, and commercialisation.
  • Prepare, compile, and submit 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.
  • Maintain accurate regulatory records and participate in audits to ensure compliance with regulatory standards.
Requirements:
  • A Bachelor's degree in a scientific discipline or 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.
  • Must be an Australian Citizen or Permanent Resident.
About the Role

You will be part of a team responsible for ensuring regulatory compliance and facilitating product development. The ideal candidate will have strong communication skills and the ability to work collaboratively with cross-functional teams.

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