Aps Level 5

2 weeks ago

Canberra, Australia National Health Funding Body Full time

**Job Reference Number **23-RPSDIV-17655

**Classification **APS Level 5

**Job Title **Case Officer (Several Positions)

**Division **Regulatory Practice and Support Division

**Branch **Regulatory Compliance Branch

**Section **Several

**Location **Fairbairn, ACT - Melbourne, VIC - Brisbane, QLD

**Status **Ongoing

**Employment type **Full-time

**Salary Range **$81,372 - $88,000

**Security Clearance **Baseline (Protected, Highly Protected, Restricted, Confidential)***

**Contact Officer Name**:Myra Kochardy
**Phone**:02 6289 3553

**Anticipated timeline for Recruitment**

**Milestone** **Date(s)**

Applications open Friday 5 May 2023

Applications close Friday 19 May 2023

Application shortlisting Thursday 1 June 2023

Interviews w/c 12 June 2023

Reference checks w/c 19 June 2023

Selection report finalisation w/c 26 June 2023

Offers and announcements w/c 10 July 2023

**Eligibility**
- To be eligible for employment with the Department of Health and Aged Care applicants

must be an Australian citizen at the time an offer of employment is made
- An applicant’s suitability for employment with Health will also be assessed through a

variety of pre-employment check processes, such as:

- Satisfactory completion of a criminal history check, and where relevant a

Working with Children and Vulnerable People Check.
- Completion of a medical declaration and pre-employment medical (where

required).
- Providing evidence of qualifications.

**Division Responsibilities**

The Therapeutic Goods Administration (TGA) is part of the Department of Health and Aged

Care. The Regulatory Practice and Support Division (RPSD) is part of the Health Products

Regulation Group (HPRG). The division is responsible for a number of regulatory functions

under the Therapeutic Goods Act 1989 and specific support services that ensure efficient,

best practice regulatory operations.

**Branch Responsibilities**

The Regulatory Compliance Branch (RCB) within the TGA undertakes regulatory compliance

activities, including education, compliance and enforcement actions to ensure compliance

with the advertising, import, manufacturing, supply and export requirements of the

Therapeutic Goods Act 1989. This includes investigations into illegal and counterfeit

therapeutic goods.

**Section Responsibilities**

**Advertising and Product Investigations Section**

The Advertising and Product Investigations Section is responsible for undertaking

compliance and enforcement activities, including investigations, to ensure the requirements

of the Therapeutic Goods Act 1989 are being met. The team focusses on the advertising

requirements for therapeutic goods and uses a risk-based approach to prioritise reports and

other signals of non-compliance. Proportionate regulatory action is taken to achieve

compliance outcomes. This includes exercising the enforcement provisions of the Act

including administrative, civil litigation and criminal prosecution.

**Compliance Assessment and Monitoring Section**

The Compliance Assessment and Monitoring Section is responsible for managing and

triaging of reports of non-compliance with advertising, import, manufacturing supply and

export requirements of the Therapeutic Goods Act 1989. The section uses a risk-based

approach to prioritise reports or other signals of non-compliance and allocate cases for

investigations in accordance with the operational, tactical and strategic priorities. The

section is also responsible for administering the advertising assurance program to assess

ongoing compliance as well as producing data analytic reports for intelligence and

monitoring.

**Product Import Compliance Section**

The Product Import and Compliance Section use a risk-based approach to prioritise reports

and or other signals of non-compliance with the Therapeutic Goods Act 1989. The section

acts in partnership with domestic and international agencies to detect, intercept and

investigate illicit therapeutic goods imported into Australia. An example is our partnership

with Australian Border Force. Together we manage import and supply of therapeutic goods,

undertaking assessments including a review of prescriptions that consumers hold to

determine if goods are imported via a lawful pathway. Where there is suspected non
- compliance, our staff use proportionate regulatory action to achieve compliance. Issues of

increased risk are referred to a more appropriate section to undertake formal investigation.

**Product Investigations Section**

The Product Investigation section uses a risk-based approach to prioritise complaints or

other signals of non-compliance using proportionate regulatory action to achieve

compliance with the Therapeutic Goods Act 1989, and where necessary prepares cases for

criminal prosecution or civil litigation. It is responsible for ongoing surveillance, enforcement

and other related activities, including investigations into illegal and counterfeit therapeutic

goods.

**Key R

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