Regulatory Affairs Leader

2 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $170,000
Job Description:

This role involves leading regulatory affairs and providing strategic leadership for a portfolio of products.

The ideal candidate will have extensive experience in Regulatory Affairs, preferably in prescription medicines within Australia and New Zealand, including Category 1 and New Medicine Applications.

  • Plan and manage local regulatory submissions for Australia and New Zealand
  • Collaborate with global, regional, and local colleagues to ensure high quality and timely applications
  • Lead cross-functional project teams to develop strategies for pipeline products
  • Provide regulatory guidance and expertise to other functions
Requirements:
  • Bachelor's Degree in Pharmacy or Science or related field
  • Extensive previous experience in Regulatory Affairs
  • Strong technical expertise working with the TGA and Medsafe
  • Excellent communication skills
  • Strong project management skills

The successful candidate will be an active member of our team, contributing to the success of our business through their regulatory expertise and leadership.

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