Aps Level 5/6

2 weeks ago

Canberra, Australia National Health Funding Body Full time

**Job Reference Number **23-MRDIV-18411

**Classification **APS Level 6 and APS Level 5

**Job Title **Compliance Evaluator and Compliance Officer (Several
Positions)

**Division **Medicines Regulation Division

**Branch **Complementary and OTC Medicines Branch

**Section **Listing Compliance Section

**Applications open date **Friday, 30 June 2023

**Applications closing date **Friday, 21 July 2023 at 11:30pm AEST

**Location **Fairbairn, ACT; Sydney, NSW; Melbourne, VIC; Brisbane, QLD

**Status **Ongoing

**Employment type **Full-time

**Salary Range **$81,372 to $102,765

**Mandatory Qualifications **A relevant qualification in medical sciences, health sciences,
chemistry, epidemiology, biochemistry, law, molecular or cell
biology, pharmacology, pharmacognosy, naturopathy,
toxicology, bioinformatics, biostatistics or any other relevant
discipline from an Australian tertiary institution or comparable
overseas qualification.***

**Contact Officer Name**:Divya Philip
**Phone**:6289 2130

**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 Medicines Regulation Division (MRD) is responsible for undertaking evaluations of

make decisions whether to approve or reject market authorisation of medicines that are

imported, exported, manufactured, and supplied in Australia.

MRD also has responsibility for ongoing monitoring of medicines approved for supply in

Australia to ensure they continue to maintain an appropriate level of quality, safety and

efficacy following entry into the Australian marketplace.

The division includes:

- Complementary and Over-the-counter Medicines Branch (COMB)
- International Regulatory Branch (IRB)
- Pharmacovigilance and Special Access Branch (PSAB)
- Prescription Medicines Authorisation Branch (PMAB)
- Scientific Evaluation Branch (SEB)

**Branch Responsibilities**

The Complementary and OTC Medicines Branch (COMB) is responsible for the regulation of

non-prescription medicines including traditional and herbal medicines, vitamin and mineral

supplements, and over-the-counter registered medicines that are supplied in Australia.

The Branch activities assure that these medicines meet standards of quality, safety and

efficacy commensurate with their level of risk. COMB undertakes market authorisation and

post-market compliance activities including:

- Post-market compliance reviews of low risk (Listed) medicines.
- Pre-market evaluations of registered over the counter and complementary

medicines.
- Assessment of new substances for use in listed medicines.
- COMB fulfils its regulatory role by collaborating with other Health branches,

regulators, stakeholders, consumers and health care professionals.

**Section Responsibilities**
- Conducting post market reviews of listed products to assess their compliance with

the regulatory requirements
- Enforcing compliance of listed medicines with the therapeutic goods legislation
- Liaising with stakeholders and sponsors in matters relating to the regulation of listed

medicines
- Monitoring, triaging and managing signals of potential non-compliance for listed

medicine

including, industry, consumers, and health professionals***

**APS Level 6 Position**

**Key Responsibilities**
- Undertaking reviews of listed medicines to determine compliance with legislative

requirements, including understanding and interpreting complex legislation and
independently preparing timely and critically considered recommendations to
resolve non-compliances and improve compliance.
- Ensuring evidence of non-compliance is meticulously captured and recorded.
- Recommending legally robust compliance/enforcement actions that are based on

risk and a synthesis of evidence/researched information and in-depth knowledge of
legislative and administrative frameworks for listed medicines.
- Investigating and monitoring high volumes of potential non-compliance signals,

conducting risk assessments to devise control strategies and influence industry
behaviour.
- Assessing products at the food/cosmetic-medicine interface and interpreting

complex legislation to determine their status as therapeutic goods.

with a standard.
- Autonomously managing multiple work tasks and competing priorities to align with

Section goals as they change over time and being accountable for the achievement
of key deliverables.
- Liaising, engaging, negotiating and collaborating with internal and external

stakeholders to resolve complex and/or se

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