APS 5 Scientific Officer - Listing Compliance Section TGA

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.

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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.

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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.

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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.

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How to Apply

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

( SK927795A )

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