CANDIDATE INFORMATION
FIRST ASSISTANT
SECRETARY
Medicines Regulation Division
Department of Health,
Therapeutic Goods
Administration
August 2021
First Assistant Secretary, Medicines Regulation Division,
Therapeutic Goods Administration
Position description
Duties
The Health Products Regulation Group (HPRG) comprises two regulators - the Therapeutic Goods
Administration (TGA) and the Office of Drug Control (ODC). It is part of Australian Government
Department of Health.
The work of the TGA is based on applying scientific and clinical expertise to decision-making, to
ensure the benefits to consumers outweigh any risks associated with the use of therapeutic goods
(including medicines, medical devices, and biologicals).
The TGA applies a risk management approach designed to ensure that therapeutic goods supplied
in Australia meet acceptable standards of quality, safety, and efficacy.
The First Assistant Secretary (FAS) is the head of the Division and has responsibility for overall
coordination of regulatory activities including consistent, high quality regulatory workflows and
outcomes, as well as driving the implementation of a range of major reform projects.
The Division Head will provide strategic guidance, leadership and direction for the development,
delivery, and monitoring of the activities of the Medicines Regulation Division and ensure that they
are consistent with the strategic directions of the Department and Government policy. This wil
include implementing strategies that ensure procedural requirements are met and decision making
is consistent with relevant legislation.
Representing the TGA and the broader 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:
• Maintaining agility to respond to COVID-19 pandemic-related priorities across
government, including working with international regulators to ensure rapid evaluation of
treatments and vaccines and a high level of post-market safety monitoring.
• Responding to scientific advancements and emerging technologies to support timely
access to new therapeutics, including gene technologies and cell and tissue products
• Reform projects that address important public health chal enges issues, for example to
address medicine shortages, better clinical trial oversight, regulation of new therapies and
repurposing of medicines.
• Participate in digital transformation of TGA’s business processes and IT systems
• Working closely with countries in the Indo-Pacific to strengthen their regulatory functions,
particular access to medicines and vaccines for COVID-19
• Manage our workforce effectively by implementing strategies that attract and retain high
quality, appropriately qualified and diverse staff.
• Create an environment where our staff are engaged and supported to undertake their
work including by responding to issues raised in staff surveys.
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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 the management of TGA's overal performance
within the Department of Health. You wil provide high quality input to the 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 multidisciplinary teams comprising large numbers of
professionally trained (science, 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 pharmaceutical and medical
sciences. Understanding and expertise in regulation and/or public sector administration is a
significant advantage.
The successful applicant wil have had demonstrated experience in a senior management position
within a complex organisation.
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 knowledge of medicines science and clinical use, together with experience in or the
ability to develop an understanding of regulatory requirements.
• 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
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• 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.
Qualifications
Tertiary qualifications in medicine and/ or postgraduate qualifications in a relevant science
discipline or pharmacy are required.
Professional experience in a medical or biomedical scientific area important 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 a 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 Medicines Regulation Division is one of HPRG’s four Divisions and is responsible for the
evaluation, market authorisation and regulation of the safety of prescription, over-the-counter and
complementary medicines, vaccines, cells, tissues, blood and blood products to ensure that they
meet appropriate standards of quality, safety and efficacy or performance, consistent with their risk.
It has a critical role in Australia’s health system, emphasised through its role in approvals and safety
monitoring of medicines and vaccine for COVID-19 during the current pandemic.
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The FAS, Medicines Regulation Division is one of 5 senior executives who form the Group
Executive. The others are:
•
Deputy Secretary, Health Products Regulation
•
Principal Policy and Legal Adviser
•
FAS, Medical Devices and Product Quality
•
FAS, Regulatory Practice and Support
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]
1. Achieves Sustained Results
Relevant capabilities and behaviours:
• organisational capability
• professional expertise
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• implements change
• ability to clarify ambiguities
• closure and delivery
2. Cultivates productive working relationships
Relevant capabilities and behaviours:
• 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
