Senior Regulatory Affairs Specialist

4 days ago

Melbourne, Victoria, Australia beBeeRegulatory Full time $220,000 - $280,000
Regulatory Specialist Role

This is a challenging opportunity for a skilled Regulatory Specialist to join our team and support the development, preparation, and submission of regulatory applications for prescription medicines and other therapeutic goods across Australia and New Zealand.

The successful candidate will play a key role in delivering high-quality regulatory outcomes, optimising submission strategies, and contributing to the continuous improvement of regulatory processes and team capability.

Key Responsibilities:
  • Submission Preparation: Prepare, review, and submit regulatory submissions for new product registrations and lifecycle maintenance variations to TGA and Medsafe.
  • Compliance Management: Ensure compliance with TGA and Medsafe regulatory frameworks.
  • Project Coordination: Manage clients and projects for assigned activities including tracking deliverables, budgets, and timelines.
  • Collaboration and Communication: Liaise cross-functionally with medical, safety, quality, and supply chain teams for compilation of submission-ready documentation.
  • Query Response: Respond to agency queries and deficiency letters within defined timelines.
  • Tracker Maintenance: Maintain internal regulatory trackers, databases, and submission archives in accordance with internal and client procedures.
  • Regulatory Framework Monitoring: Monitor changes in local regulatory framework and communicate impact assessments as needed.
Requirements:
  • Education: Bachelor's or master's degree in pharmacy, Life Sciences, or a related field.
  • Experience: 3 to 4 years of Regulatory Affairs experience with direct involvement in prescription medicine regulatory submissions.
  • Skills: Hands-on experience with TGA and Medsafe regulatory procedures, including preparation and submission of CTD dossiers.
  • Project Management: Strong project management experience in regulatory operations, with proven ability to coordinate cross-functional inputs and meet submission timelines.
  • Market Knowledge: Sound understanding of regulatory requirements across the Australian and New Zealand markets.
  • Communication Skills: Excellent written and verbal communication skills with strong attention to detail.
  • Independence: Ability to manage multiple priorities and work independently in a dynamic regulatory environment.

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