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.