Regulatory Affairs Specialist

2 weeks ago

Melbourne, Victoria, Australia beBeeRegulatory Full time $90,000 - $120,000
Regulatory Affairs Expertise

The RQC function supports the development, preparation, and submission of regulatory applications for prescription medicines and other therapeutic goods across Australia and New Zealand. This role involves managing regulatory projects from planning through execution, working collaboratively with internal teams and clients to ensure compliance with local regulatory requirements. The Regulatory Affairs Consultant plays 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:
  • 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 clients and projects for assigned activities including tracking deliverables, budgets, and 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 and client 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.
  • 3-4 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.

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