Regulatory Affairs Expert

2 days ago


Melbourne, Victoria, Australia beBeeRegulatory Full time $220,000 - $280,000
Regulatory Affairs Professional

Job Overview:

  • We are seeking a skilled Regulatory Affairs professional to manage regulatory projects from planning through execution.
  • The ideal candidate will collaborate with internal teams and clients to ensure compliance with local regulatory requirements.

Main Responsibilities:

  • Prepare, review, and submit regulatory submissions for new product registrations and lifecycle maintenance variations to regulatory agencies.
  • Ensure compliance with regulatory frameworks and maintain accurate records.
  • Liaise cross-functionally with medical, safety, quality, and supply chain teams for compilation of submission-ready documentation.

Key Requirements:

  • Bachelor's or master's degree in pharmacy, Life Sciences, or a related field.
  • 3-4 years of experience in Regulatory Affairs with direct involvement in prescription medicine regulatory submissions.
  • Hands-on experience with regulatory procedures, including preparation and submission of CTD dossiers.

This is an excellent opportunity for a detail-oriented and organized professional to join our team.



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