CANDIDATE INFORMATION
FIRST ASSISTANT
SECRETARY
Legal and Policy Adviser
Department of Health,
Therapeutic Goods
Administration
August 2021
First Assistant Secretary, Principal Legal and Policy Adviser,
Therapeutic Goods Administration
Position description
Duties
The Principal Legal and Policy Adviser wil provide strategic guidance, leadership and direction for
the development, delivery, and monitoring of the activities of the Regulatory Legal Services team
and ensure that they are consistent with the strategic directions of the Department and
Government policy.
In addition to leadership and management of the Group’s legal team, the Principal Adviser is also
expected to provide Group wide advice on complex legal and regulatory policy issues. The
Principal Adviser will also personally have leadership of a small number of high-profile cross-
cutting projects. A recent example is leading development and implementation of a new regulatory
framework for nicotine e-cigarettes to support national smoking cessation efforts.
The position will also be representing the Department in senior level discussions with industry,
Government, and other relevant parties both national y and international y.
The key responsibilities of the role are:
• Provide leadership in delivering outputs of HPRG’s regulatory process that are legal y robust
• Provide regulatory advice on the review and development of legislation taking into account
government and stakeholder expectations
• Provide policy and legal advice on:
o Matters relating to complex regulatory decisions made under the legislation
o Leadership of risk management for the Therapeutic Goods Administration and
Office of Drug Control
o Decisions on product regulatory compliance, including enforcement actions and
litigation
• Lead, support and develop lawyers within the Group
• Ensure consistency between Group-wide process and the regulatory framework and
facilitate the development of regulatory policy underpinning the legislation and its
implementation
• Represent the organisation in high level discussions and negotiations; undertake
negotiations in a range of high level national and international forums
• Provide expert advice and instruction in enforcement actions, including in relation to
matters before the Federal Court and the Administrative Appeals Tribunal
• Support the development of the Department’s regulatory capacity
The appointee wil be part of the Group and Department’s leadership cohort and wil need to
develop familiarity with the regulatory functions of the Group and priorities and programs of the
broader Department.
You wil provide advice and assistance to the Deputy Secretary, Secretary and Minister for Health in
setting the strategic direction for the TGA and ODC. You wil provide high quality input to the
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development and/or review of regulatory practices, providing strategic and operational cohesion
between individual projects and programs to promote a consistent approach. You wil be
comfortable from a technical and management perspective in leading a legal team as well as in
collaborating with scientific and medical staff.
Relevant Experience
The successful applicant wil have had demonstrated experience in a senior management position
within a complex organisation, you wil be experienced in providing strategic leadership and
direction and building the capability of your team and the organisation more broadly.
You wil need to be forward thinking, self-motivated, resilient, and adept at building relationships in
a large complex and fast-paced environment. Your strong leadership credentials and ability to
engender trust and respect wil be complemented by sound judgement, a strong focus on results
and the ability to resolve complex issues in a public sector context, including by winning support,
marshal ing resources and leveraging relationships.
The position requires training in and significant understanding of administrative law and policy
development. Understanding and expertise in regulation and public sector administration is a
significant advantage.
Leadership and Personal Attributes
The TGA is seeking leaders with:
• An exceptional results orientation based on leading by example with a resilient and positive
approach to issues resolution
• Proven ability to lead legal professionals in a diverse scientific/regulatory based organisation,
and to col aborate with others in areas outside their own professional legal training
• A solid understanding of, and experience at a senior level in administrative law in Australia
• A focus on nurturing people and relationships to ensure an inclusive and col aborative
approach, where people are chal enged and supported to be creative, innovative, and
contribute to the best of their ability
• Experience in leading and implementing major organisational change.
• The ability to develop an understanding of regulatory requirements for therapeutic goods.
• The ability to confidently manage and lead in a dynamic environment. This includes the ability
to create and unite people behind a strategic vision, astute judgement, political nous, engaging
with positively and creatively with risk, and the ability to lead and support people through
change
• First class communication and interpersonal skills that build relationships based on
understanding, respect and trust, ensuring Health listens to and learns from stakeholders
• The intelligence, persuasiveness, professionalism, authenticity and credibility necessary to
leverage both formal and informal authority
• Excellent self-awareness and a proactive approach to their own personal and professional
development, to the development and of their staff and to building the capability of the
organisation.
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Qualifications
Tertiary qualifications in a relevant legal discipline and experience in administrative law is required.
Experience in a health, regulatory or a technical environment would be an advantage.
Remuneration
These are critical senior appointments and the remuneration packages wil therefore be structured
to attract and retain outstanding appointees. The packages wil include an attractive base salary,
an executive vehicle al owance (cash), non-cash benefits (such as parking, airport lounge
membership, learning and development and IT equipment) and employer sponsored
superannuation.
Location
The position is based in Symonston, ACT (relocating to Fairbairn ACT in early 2022).
Assistance with Relocation
Assistance with removal expenses and / or short term accommodation assistance may be provided
if interstate relocation is involved.
Other Conditions
To be employed by the Department of Health applicants must be Australian citizens or have
permanent residency status pending the granting of Australian citizenship.
These are positions of trust and successful candidates wil be subject to an Negative Vetting 1
security clearance.
RecruitAbility
RecruitAbility applies to this vacancy. You wil be invited to participate in further assessment activity
for the vacancy if you choose to apply under the RecruitAbility scheme; declare you have a
disability; and meet the minimum requirements for the job. For more information see:
www.apsc.gov.au/priorities/disability/recruitability. The Department
Background
The Principal Legal and Policy Adviser is a member of the HPRG’s Executive and contribute to the
setting of the strategic direction of HPRG and the wider department. They also have line
responsibility for a team of over 20 lawyers and paralegals. The role is the chief risk manager for
the Group, providing counsel to assist decision makers to assess risks and make decisions on
complex regulatory and policy matters that are legal y sound and supported by appropriate
reasoning.
The other members of the Group Executive are:
• Deputy Secretary, Health Products Regulation
• FAS, Medicines Regulation Division
• FAS, Medical Devices and Product Quality
• FAS, Regulatory Practice and Support
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The Department’s Behaviours in Action
To achieve the Department’s vision, the Executive fosters a culture where al staff:
• Col aborate to innovate – work with others to make a difference
• Invest in high performance – nurture talent and builds capability in others
• Trust and empower – build trust to exercise responsibility
• Listen and appreciate – listen with intent and value contributions
• Walk the talk – lead by example and embrace change
Further information about the Department can be found at:
https://www.health.gov.au/about-us
APS Values
Every person in the Department is expected to uphold the Australian Public Service (APS) Values of
being:
• Impartial – The APS is apolitical and provides the Government with advice that is frank, honest,
timely and based on the best available evidence
• Committed to service – The APS is professional, objective, innovative and efficient, and works
col aboratively to achieve the best results for the Australian community and the Government
• Accountable – The APS is open and accountable to the Australian community under the law and
within the framework of Ministerial responsibility
• Respectful – The APS respects al people, including their rights and their heritage
• Ethical – The APS demonstrates leadership, is trustworthy, and acts with integrity in al that it
does.
Preparing your application and how to apply
Your application should include a CV, covering letter and a response of no more than one page, to
the following selection criteria.
In preparing your response, it is in the interest of candidates to present their application in a way
that demonstrates significant outcomes associated with each of the fol owing criteria, as well as the
capabilities and behaviours that underpin them (please note that it is not necessary to address the
capabilities and behaviours individual y).
[Insert how to apply and EIG contact information here]
Selection criteria
1. Achieves Sustained Results
Relevant capabilities and behaviours:
• organisational capability
• professional expertise
• implements change
• ability to clarify ambiguities
• closure and delivery
2. Cultivates productive working relationships
Relevant capabilities and behaviours:
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• nurtures internal and external relationships
• facilitates co-operation and partnerships
• values differences and diversity
• guides, mentors and develops people
3. Exemplify personal drive and integrity
Relevant capabilities and behaviours:
• professionalism and probity
• risk-taking and personal courage
• action orientation
• resilience
• self-awareness
• commitment to personal development
4. Communicates with influence
Relevant capabilities and behaviours:
• communicates clearly
• listens, understands and adapts to different audiences
• negotiates persuasively
5. Shapes strategic thinking
Relevant capabilities and behaviours:
• inspires a sense of purpose and direction
• strategic focus
• ability to recognise opportunities, harness information
• shows judgement, intelligence and common sense
6. Professional Capability
Professional skills, knowledge and experience that demonstrate the applicant’s professional standing
and competency.
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Document Outline