Senior Regulatory Specialist

1 week ago

Melbourne, Victoria, Australia beBeeRegulatory Full time $80,000 - $120,000
Regulatory Specialist Position Overview

This role is centered around supporting regulatory submissions for prescription medicines and therapeutic goods across Australia and New Zealand.

The Regulatory Affairs team plays a crucial part in ensuring compliance with local regulatory frameworks, preparing and submitting high-quality regulatory documents to relevant authorities, and maintaining up-to-date knowledge of regulatory requirements.

Key Responsibilities:
  • Prepare, review, and submit regulatory submissions to the Therapeutic Goods Administration (TGA) and Medsafe.
  • Ensure that all regulatory submissions meet the required standards and are submitted within the designated timelines.
  • Manage client relationships and projects assigned to the role.
  • Liaise with internal teams to ensure submission-ready documentation.
  • Respond to agency queries in a timely manner.
  • Maintain accurate records and databases of regulatory trackers.
  • Stay informed about changes in local regulatory frameworks.
Requirements:
  • A degree in pharmacy or a related field such as Life Sciences.
  • 3-4 years of experience in Regulatory Affairs with direct involvement in prescription medicine regulatory submissions.
  • Hands-on experience working with TGA and Medsafe procedures.
  • Strong project management skills in regulatory operations.
  • Solid understanding of the Australian and New Zealand markets.
  • Excellent written and verbal communication skills.
  • Ability to prioritize tasks and work independently.

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