Job title
Salary
Accountable to
Contract
Location
Introduction
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Regulation Manager
Band 4
Head of Regulation
Permanent
151 Buckingham Palace Road
London, SW1W 9SZ
The Human Tissue Authority (HTA) is the national independent regulator for organisations that remove, store and use tissue for research, medical treatment, post-mortem examination, teaching and display in public. We also give approval for organ and bone marrow donations from living people. With the interests of the public and those we regulate at the centre of our work, we aim to maintain confidence by ensuring that human tissue is used safely and ethically, with proper consent.
Established under the Human Tissue Act (2004), we are an Executive Non-
Departmental Public Body (ENDPB) sponsored by the Department of Health.
The Authority’s Chair and members are appointed by the Secretary of State for Health. The Chair and half of the members are lay, with the remainder being professionals drawn from some of the groups who are affected by the legislation. The Authority is supported by an Executive team of 50 staff.
Job purpose
The role has three core responsibilities:
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to lead (or support) inspections and investigations, and make associated licensing decisions including making recommendations to senior colleagues where significant regulatory action is required ;

to provide advice and guidance to a broad range of colleagues and external stakeholders;
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to lead (or contribute to) projects within HTA, and; to lead (or contribute to) the development and implementation of regulatory policies.
1

Communication and working relationships
Internal contacts
Staff within the Regulation Directorate, as well as across the organisation in the HTA’s three other directorates: Communications, Strategy and Quality and
Resources. Internal contacts also include the Senior Management Team
(SMT) and Authority Members.
The postholder will be managed by a Head of Regulation and is required to report to them on all issues within the scope of the post’s responsibilities.
External contacts
Key stakeholders and groups, who require advice and guidance on statutory and regulatory requirements and have sector-specific interests in regulated activities; for example, professional Colleges and associations.
Those regulated by HTA, including those who are subject to licensing and inspection.
Other partners, such as the Department of Health, Ministry of Justice, Home
Office, Care Quality Commission, Health Research Authority, Human
Fertilisation and Embryology Authority, Medicines and Healthcare Products
Regulatory Agency, and any other relevant agencies.
Key tasks and responsibilities
1. To lead (or support) inspections and investigations and make associated licensing decisions.
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To lead and support inspections and investigations in all sectors across the UK, ensuring that all relevant standard operating procedures (SOPs) and guidance are followed.
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To make evidence-based, proportionate and defensible risk based licensing decisions and recommendations
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To assess and monitor compliance with licence conditions, HTA
Codes of Practice, licensing standards, and other HTA guidance.
2. To provide advice and guidance to a broad range of individuals and groups.
2


To provide clear, evidence-based advice and guidance in a variety of formats (including professional presentations) to a range of audiences, both within HTA and outside of it.
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To share expertise with HTA staff.
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To manage professional relationships with key stakeholders.
3. To lead (or contribute to) projects within HTA.
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In leading (or contributing to) projects within HTA, to ensure effective management of the associated people and resources.
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To lead (or contribute to) the development and implementation of robust systems and processes for licensing, inspections, investigations and enforcement.
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To lead (or contribute to) the development of SOPs and the quality guidance manuals for all activities within the Regulation Directorate.
4. To lead (or contribute to) the development and implementation of regulatory policies.
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To work collaboratively with colleagues to review and evaluate the options available, and present written papers to SMT and other groups as required.
Other responsibilities
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To matrix manage, project manage and line manage staff as required

To be a proactive member of the regulation team
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To support the Heads of Regulation and the Director of Regulation as required
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To represent HTA on relevant matters as and when required
3

Person specification
Criteria
Experience, training and skills
Read and analyse large quantities of complex information and identify key issues
Demonstrate good judgement
Gather evidence to assess progress against agreed standards
Excellent level of writing skills and the ability to clearly document and all aspects of their work
Ability to communicate effectively with the public and professionals in a variety of formats
Ability to present to groups of people using appropriate visual aids
Ability to effectively manage resources and people as part of a project
Ability to prioritise and organise work
Ability to work effectively under pressure and handle disagreements positively
Flexibility to work alone or as part of a team
PhD
Experience of project management
A background and / or experience in regulation or one of the sectors regulated by HTA, in particular the post mortem sector
Experience of matrix or line management
Essential
Desirable
Desirable
Desirable
Desirable
Essential
Essential
Essential
Essential
Essential
Essential
Essential
Essential
Essential
4

Experience of writing documents for publication
Experience of budget control
Personal attributes
Excellent interpersonal skills
Competencies
Gaining awareness and understanding
Creating effective solutions
Understanding others
Facilitating teamwork
Developing people and capability
Building relationships
Inspiring confidence
Compelling communication
Achieving results
Concern for quality
Desirable
Essential
Level 3
Level 2
Level 2
Level 2
Level 2
Level 2
Level 3
Level 3
Level 3
Level 3
5