Senior Regulatory Affairs Specialist

2 days ago

Melbourne, Victoria, Australia beBeeExpert Full time $90,000 - $130,000
Regulatory Affairs Role Overview

This is a high-profile opportunity for an experienced Regulatory Affairs professional to contribute to delivering regulatory outcomes across Australia and New Zealand.

  • Key responsibilities will include preparing, reviewing, and submitting regulatory dossiers to Medsafe and TGA as required.
  • Compliance with relevant regulatory frameworks and guidelines must be ensured at all times.
  • The successful candidate will serve as the regulatory project coordinator for assigned submissions.
  • Effective collaboration with cross-functional teams including medical, safety, quality, and supply chain teams will be essential.
Requirements

To be considered for this role, you will require:

  • A bachelor's degree in science, pharmacy or a related discipline.
  • A minimum of 5 years' experience in regulatory affairs is necessary.
  • Strong written and oral communication skills are crucial.
What We Offer

This is a unique opportunity to collaborate with leading experts in regulatory affairs and contribute to projects that have real-world impact on patient care.

  • Collaborate with talented professionals in regulatory affairs.
  • Contribute to projects that make a meaningful difference to healthcare outcomes.
Why You'll Thrive Here

We're looking for someone who can bring their expertise and passion to our team. If you have:

  • Excellent knowledge of legislation, regulations, guidelines, and working procedures within Australia, New Zealand, and the JAPAC region.
  • Proven problem-solving and project management skills.
  • Good computer literacy.
  • Ability to handle confidential information.

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