This position is no longer open for applications

APS 5 Scientific Officer - Listing Compliance Section TGA

APS 5 Scientific Officer - Listing Compliance Section TGA (BBBH36342) Canberra, Australia

Salary: AUD41 - AUD44 per hour

About the company

Listing Compliance Section (LCS) of the Complementary & OTC Medicines Branch (COMB) of the TGA is responsible for the regulatory compliance of listed and non-prescription medicines.

 

 

 

About the opportunity

The APS 5 Scientific Officer will be responsible for pre-market evaluations of scientific evidence, reviewing quality and safety, ensuring regulatory compliance, and post market compliance.

This is a 12-month contract until April 22nd 2022.

 

 

 

Duties

  • Conduct investigations and risk assessments into signals of potential breaches of therapeutic goods legislation.
  • Exercise sound scientific judgement in recommending risk-based compliance enforcement actions to decision makers.
  • Undertake compliance reviews of listed medicines, including preparing timely, high quality technical and scientific reports.
  • Analyse internal compliance monitoring data to inform targeted compliance actions and compliance strategies.
  • Maintain the section’s compliance databases, reports, and quality management system, including developing and maintaining Standard Operating Procedures.
  • Prepare correspondence and education products for diverse stakeholders relating to regulation of low-risk medicines and outcomes of evaluations, reviews, and assessments.

 

 

 

Skills and Experience

  • Tertiary qualification in chemistry, pharmacology, nutrition, or relative science subject
  • Experience with TGA legislation and policy frameworks
  • Ideally have experience with data analytics and relevant IT systems
  • Ability to support government teams in regulatory, legal or compliance environments.

 

 

 

How to Apply

Click apply or contact Joanna Murphy, Senior Recruitment Consultant on 02 8877 8718 for a confidential discussion.

;