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Regulatory Affairs Specialist

2 weeks ago

Melbourne, Victoria, Australia beBeeRegulatory Full time $100,000 - $140,000
Job Overview:

The Regulatory Affairs Specialist plays a pivotal role in delivering high-quality regulatory outcomes, optimising submission strategies, and contributing to the continuous improvement of regulatory processes and team capability.

Key Responsibilities:

  • Prepare, review, and submit regulatory submissions for new product registrations and lifecycle maintenance variations to TGA and Medsafe.
  • Ensure compliance with TGA and Medsafe regulatory frameworks.
  • Manage client relationships and projects for assigned activities including tracking deliverables, timelines.
  • Liaise cross-functionally with medical, safety, quality, and supply chain teams for compilation of submission-ready documentation.
  • Respond to agency queries and deficiency letters within defined timelines.
  • Maintain internal regulatory trackers, databases, and submission archives in accordance with internal procedures.
  • Monitor changes in local regulatory framework and communicate impact assessments as needed.

Requirements:

  • Bachelor's or master's degree in pharmacy, Life Sciences, or a related field.
  • 3 to 4 years of Regulatory Affairs experience with direct involvement in prescription medicine regulatory submissions.
  • Hands-on experience with TGA and Medsafe regulatory procedures, including preparation and submission of CTD dossiers.
  • Strong project management experience in regulatory operations, with proven ability to coordinate cross-functional inputs and meet submission timelines.
  • Sound understanding of regulatory requirements across the Australian and New Zealand markets.
  • Excellent written and verbal communication skills with strong attention to detail.
  • Ability to manage multiple priorities and work independently in a dynamic regulatory environment.

Why You'll Thrive:

  • Foster a culture of excellence and continuous improvement.
  • Develop your skills in regulatory affairs and stay up-to-date with industry trends.
  • Collaborate with a talented team to drive business success.