Aps Level 6

**Job Reference Number **22-MRDIV-14927
**Classification **APS Level 6
**Job Title **Compliance Evaluator (Several Positions)
**Division **Medicines Regulation Division
**Branch **Complementary and OTC Medicines Branch
**Section **Listing Compliance Section
**Location **Fairbairn, ACT; Sydney, NSW; Melbourne, VIC; Brisbane, QLD
**Status **Ongoing
**Employment type **Full-time
**Salary Range **$88,439 - $99,772
**Security Clearance **None***
**Mandatory Qualifications **A relevant qualification in toxicology, chemistry, epidemiology,

biochemistry, molecular or cell biology, medical sciences,
pharmacology, pharmacognosy, biostatistics, nutrition, dietetics,
law or any other relevant discipline from an Australian tertiary
institution or comparable overseas qualification.***

**Contact Officer Name**:Kirsty Craig
**Phone**:(02) 6289 1674

**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)
- 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’s 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**
The Listing Compliance Section (LCS) is responsible for:

- Auditing and enforcing the compliance of listed medicines included in the Australian

Register of Therapeutic Goods (ARTG) with regulatory requirements.
- Evaluating scientific evidence of efficacy held by sponsors to support indications and

claims for listed medicines included in the ARTG.
- Reviewing the quality and safety of listed medicines included in the ARTG.
- Liaising with stakeholders and sponsors in matters relating to the regulation of listed

medicines.
- Undertaking business improvement projects to improve the efficiency and risk-based

targeting of compliance activities for listed medicines.
- Contributing to the education of sponsors about the regulatory requirements for

listed medicines.
- Providing strategic input into regulatory reform projects relating to listed medicines.***

**Key Responsibilities**
Specific duties include:

- Undertaking compliance reviews of listed medicines, including independently

preparing timely, high quality technical assessments of submitted data (related to
quality, safety and/or efficacy) to determine compliance with legislative
requirements.
- Investigating and monitoring signals of non-compliance related to listed medicines;
conducting risk assessments to identify control measures and devise strategies to
address compliance deficiencies and influence industry behaviour.
- Assessing products at the food/cosmetic-medicine interface and interpreting

legislation to determine their status as therapeutic goods.

with a standard.
- Recommending robust risk-based regulatory decisions and enforcement strategies to

improve compliance in the sector, based on research, synthesis of information and

frameworks for listed medicines.
- Implementing an individual and dynamic work plan, including setting tasks and

priorities that align with team goals, managing workflows and taking responsibility
for the achievement of