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Job details

Location
Canberra, Australian Capital Territory
Salary
AU$41 - AU$44 per hour
Job Type
Contract
Ref
BBBH36342_1618884546
Contact
Joanna Murphy
Contact email
Email Joanna
Contact phone
+61 2 88778718
Posted
28 days ago

Job details

Location
Canberra, Australian Capital Territory
Salary
AU$41 - AU$44 per hour
Job Type
Contract
Ref
BBBH36342_1618884546
Contact
Joanna Murphy
Contact email
Email Joanna
Contact phone
+61 2 88778718
Posted
28 days ago

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.

( SK927795A )

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