Regulatory Affairs Specialist

1 day ago

Melbourne, Victoria, Australia beBeeRegulatoryAffairs Full time $220,000 - $280,000
About the Role

The Regulatory Affairs Specialist plays a pivotal role in ensuring compliance with local regulatory requirements.

  • 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.

To achieve this, you will be responsible for managing clients and projects, tracking deliverables, budgets, and timelines.

Liaising cross-functionally with medical, safety, quality, and supply chain teams is also an essential aspect of this role.

You will respond to agency queries and deficiency letters within defined timelines.

Maintaining internal regulatory trackers, databases, and submission archives in accordance with internal and client procedures is crucial.

Monitoring changes in local regulatory framework and communicating impact assessments as needed is another key responsibility.

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.

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