Senior Regulatory Specialist

1 week ago

Canberra, ACT, Australia beBeeRegulatory Full time $108,680 - $123,951
Job Title

Senior Professional Officer

We are seeking a highly skilled Senior Professional Officer to join our Medicines Regulation Division. The role involves undertaking evaluations of medicines and making decisions on their approval or rejection for market authorisation in Australia.

Division Responsibilities

The Medicines Regulation Division is responsible for protecting public health and safety by regulating therapeutic goods, such as medicines, medical devices, biologicals, human blood, blood products, and tissues.

Mission Critical Functions

This role will play a key part in the ongoing monitoring of medicines approved for supply in Australia to ensure they continue to maintain an appropriate level of quality, safety and efficacy following entry into the Australian marketplace.

Key Accountabilities
  • Evaluation and Decision Making: Undertake thorough evaluations of medicines to determine their suitability for approval or rejection for market authorisation in Australia.
  • Post-Market Monitoring: Conduct regular reviews of medicines approved for supply in Australia to ensure they continue to meet required standards of quality, safety, and efficacy.
  • Stakeholder Engagement: Engage with internal and external stakeholders to provide accurate advice and support on medicine shortages and regulatory matters.
  • Leadership and Collaboration: Provide leadership and guidance to team members, and collaborate with cross-functional teams to achieve strategic objectives.
Requirements

To be successful in this role, you will need:

  • A bachelor's degree in a relevant field, such as pharmacy, pharmacology, or science.
  • At least 3 years' experience in a related field, preferably in a regulatory or pharmaceutical context.
  • Demonstrated expertise in evaluation and decision-making, post-market monitoring, and stakeholder engagement.
  • Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
Benefits

As a valued member of our team, you will enjoy:

  • A competitive salary and benefits package.
  • Ongoing professional development and training opportunities.
  • A dynamic and supportive work environment.

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