Aps Level 6

**Job Reference Number **23-MRDIV-16568

**Classification **APS Level 6

**Job Title **Toxicologist (Several Positions)

**Division **Medicines Regulation Division

**Branch **Scientific Evaluation Branch

**Section **Toxicology Section

**Location **Fairbairn, ACT

**Status **Ongoing

**Employment type **Full-time

**Salary Range **$88,439 - $99,772

**Mandatory Qualifications **A relevant qualification in the biological sciences from an
Australian tertiary institution, or comparable overseas
qualifications.***

**Contact Officer Name**:Dr Iain Sharpe
**Phone**:02 6289 2604

**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 an Australian Federal Police 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 part of the Health Products Regulation Group in

medicines for supply in Australia. It also undertakes safety monitoring of medicines and

vaccines approved for supply in Australia after they are on the market.

**Branch Responsibilities**

biologicals and generic medicines in Australia and provides scientific advice to support the

decisions made by the Medicines Regulation Division, evaluating the toxicological and

pharmaceutical chemistry aspects of therapeutic products and provide expertise in the

biological sciences.

**Section Responsibilities**

The Toxicology Section is responsible for the evaluation and interpretation of the

pharmacological, toxicokinetic and toxicological data submitted for a wide variety of

products, including prescription, non-prescription and complementary medicines,

biologicals, vaccines, cell and tissue products and drug/device combinations. The section

provides expert advice at all stages of the product lifecycle, from early therapeutic product

development to post-marketing safety reviews, so that informed decisions can be made on

the relative risks and benefits of these therapeutic products.

**Key Responsibilities**
- Independently analyse and critically evaluate _in vitro _and animal data on pharmacology,

pharmacokinetics and toxicity, including addressing any deficiencies in the submitted

information.
- Preparation of comprehensive written scientific assessments that consider the risks to

humans from the use of therapeutic products, that have been identified from nonclinical

data/information and using international best-practice methodology.
- Provision of scientific recommendations consistent with the regulatory framework under

which the TGA operates.
- Liaise, engage and collaborate with internal and external stakeholders as required in

support of the TGA’s regulatory responsibilities.

**Key Capabilities**
- Strong analytical and problem resolution skills.
- Excellent written and oral communication skills, with a high level of attention to detail.
- Under broad direction, manage own workflow to ensure the flexible and timely delivery

of assessments and advice.
- Co-operate effectively and proactively in a team environment; and to engage positively

with feedback and learning & development.
- A sound understanding of the regulatory framework for therapeutic goods in Australia,

including applicable standards and guidelines, or the demonstrated ability to rapidly
- Participate in the continuous improvement of scientific capability and business

processes of the section and branch.

**Minimum Requirements**

RecruitAbility is a scheme which aims to attract and develop applicants with disability and

also facilitate cultural changes in selection panels and agency recruitment. All vacancies for

the Department of Health and Aged Care are advertised under the RecruitAbility Scheme.
- Job applicants with disability who:

- opt into the scheme
- declare they have disability, and
- meet the minimum requirements of a vacancy advertised under the scheme

are advanced to a further stage in the selection process.
- More information on RecruitAbility can be found here: RecruitAbility scheme: A guide for

applicants

Minimum requirements for this role include:

- A relevant qualification in the biological sciences from an Australian tertiary institution,

or comparable overseas qualifications.
- Strong analytical and problem resolution skills.
- Excellent written and oral communication skills, with a high level of attention to detail.

**Desirable Qualifications & Experience**
- Postgraduate qualification(s) together with research and/or industry experience in any

of the relevant areas of expertise
- Relevant areas of expertise inc