Regulation and Policy Lead, AI for Medicines Safety - £62,905 - £70,817 p.a. + benefits

Job summary

We are currently looking for a Regulation and Policy Lead, AI for Medicines Safety to join our Benefit Risk Evaluation IFunctionwithin the Safety & Surveillance Group.

This is a full-time opportunity, on a permanent basis. The role will be based in 10 South Colonnade, Canary Wharf London, E14 4PU.

Government departments and agencies are working towards implementing a minimum 60% attendance in office sites.

We are currently implementing a flexible, hybrid way of working, with a minimum of 8 days per month working on site to enable the collaboration and contact with partners and stakeholders needed to deliver MHRA business. Attendance on site is driven by business needs so depending on the nature of the role, this can flex up to 12 days a month, with the remainder of time worked either remotely or in the office. Some roles will need to be on site more regularly. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.

The Safety and Surveillance (S&S) Group brings together into a single integrated structure expertise on the safety of all medical products with enforcement capabilities. These functions are supported by the Agency’s data and evidence generating capabilities, complementing our signal generating abilities.

Against this background and the drive to improve treatment availability for patients, safety remains at the heart of all our decision making across the product life cycle. The central mission of the Safety & Surveillance portfolio is to protect the public by appropriately identifying, assessing and managing the risks associated with medical products. In every aspect of this work, we harness the best science, technology, information and professional practice to protect patients in new and impactful ways.

The core purpose of Benefit Risk Evaluation is to deliver a robust assessment of potential safety signals using data from a range of sources along with technical, scientific, clinical and regulatory knowledge, and practical experience. The team conducts benefit-risk evaluations for medicines and medical device across a broad spectrum of therapeutic areas to guide actions that protect patient safety. The team is responsible for:

• Signal detection of emerging safety issues
• Evaluating the benefit risk of signals and developing effective and measurable risk mitigation measures
• Using data and embracing new technologies to develop the evidence to support our actions and understand their impact

Job description

Role Purpose

This is an exciting opportunity to play a lead regulatory and policy role in the delivery of the MHRA's “Beyond ADMET: AI for Medicines Safety” regulatory sandbox. This unique regulatory science initiative will explore how artificial intelligence can improve the prediction of absorption, distribution, metabolism, excretion and toxicity (ADMET) outcomes and integrate clinical and real-world data to support safer, faster and more efficient medicines development.

Working closely with the Head, AI for Medicines Safety and the Technical Lead, the postholder will provide specialist regulatory and policy expertise across the programme, ensuring that sandbox activities are aligned with current regulatory frameworks and helping to assess the implications of emerging AI-enabled approaches for medicines development and safety assessment.

The postholder will support the identification and interpretation of emerging regulatory, scientific and policy developments relating to artificial intelligence, computational methods and non-clinical medicines development. They will work collaboratively with colleagues across the MHRA, government, industry, academia and international regulatory networks to support evidence generation, regulatory learning and policy development arising from the programme.

Initially focused on supporting delivery of the “Beyond ADMET: AI for Medicines Safety” regulatory sandbox programme, the postholder will also contribute to the MHRA's broader ambitions in AI-enabled regulatory science and innovation, with opportunities to apply their expertise across other priority areas as organisational needs evolve.

The role offers a unique opportunity to contribute to the future development of AI-enabled medicines regulation while helping strengthen the MHRA's position as a global leader in regulatory innovation and patient safety.

Key responsibilities

Regulatory and Policy Leadership

• Lead on all aspects of regulatory and policy advice on AI-enabled approaches in medicines development, safety assessment and related scientific areas.
• Shape the MHRA's regulatory thinking on emerging AI methodologies and technologies, ensuring outputs from the sandbox inform future regulatory approaches and policy development. Drive horizon scanning and strategic assessment of UK and international regulatory, policy and scientific developments relevant to AI, toxicology, pharmacology, ADMET prediction and medicines development.
• Lead the interpretation and application of current legislation, regulatory frameworks and guidance relevant to programme activities.

Programme Delivery

• Work closely with the Head, AI for Medicines Safety, Technical Lead and Programme Manager to ensure effective integration of regulatory, scientific and operational considerations across the programme.
• Provide regulatory and policy leadership on programme planning, delivery and evaluation activities.
• Develop programme outputs including reports, recommendations, briefings, workshops and publications.

Stakeholder Engagement

• Build effective relationships with stakeholders across the MHRA, government departments, academia, industry, healthcare organisations and international regulatory networks.
• Represent the programme in regulatory and policy discussions with internal and external stakeholders, communicating regulatory and policy considerations clearly to technical and non-technical audiences.

Regulatory Science and Governance

• Lead on the development of future regulatory frameworks, guidance and policy approaches where appropriate. Identify opportunities to strengthen MHRA capability and leadership in AI-enabled regulation.
• Ensure regulatory activities are delivered in accordance with MHRA governance requirements, quality standards and best practice. Maintain accurate documentation and evidence to support programme outputs and recommendations.

General

• While the immediate focus of this role is the successful delivery of the “Beyond ADMET: AI for Medicines Safety” regulatory sandbox, the postholder will be expected to contribute regulatory and policy expertise across the Agency's evolving AI and regulatory science agenda.
• Champion the MHRA values and Civil Service behaviours, promoting an ethical, positive and inclusive working environment.

The duties and responsibilities outlined above are not intended to be exhaustive and may be reviewed or amended from time to time in consultation with the postholder to meet organisational needs.

Person specification

Essential Criteria:

• Experience working in regulatory affairs, regulatory policy, regulatory science or a related discipline within healthcare, life sciences or a related sector - Lead
• Experience interpreting and applying regulatory frameworks to new technologies, scientific approaches, products or services.
• Experience advising on regulatory or policy issues and translating complex information into practical recommendations.
• Experience contributing to regulatory guidance, policy development, standards development or regulatory science initiatives.
• Experience engaging effectively with stakeholders across government, academia, industry, healthcare organisations or regulatory bodies.
• Experience working collaboratively within multidisciplinary projects, programmes or teams.

Qualifications

Degree in a relevant scientific, healthcare, policy or regulatory discipline (or equivalent experience).

Behaviours

We'll assess you against these behaviours during the selection process:

• Communicating and Influencing
• Working Together
• Making Effective Decisions

Technical skills

We'll assess you against these technical skills during the selection process:

• Degree in a relevant scientific, healthcare, policy or regulatory discipline (or equivalent experience).
• Understanding of medicines regulation, non-clinical assessment and emerging technologies.
• Knowledge of regulatory policy development processes and regulatory science principles.
• Ability to critically evaluate scientific evidence and assess regulatory implications.
• Understanding of artificial intelligence and machine learning concepts and their application within healthcare and life sciences.
• Awareness of UK and international regulatory approaches relating to AI-enabled technologies.
• Strong written and verbal communication skills, including preparation of briefings, reports and recommendations for senior audiences.

We only ask for evidence of these technical skills on your application form:

• Understanding of medicines regulation, non-clinical assessment and emerging technologies.

Benefits

Alongside your salary of £62,905, Medicines and Healthcare Products Regulatory Agency contributes £18,223 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides (opens in a new window).

• Annual Leave: 25 days annual leave on entry, rising by one day for each completed year of service to a maximum of 30 days and pro-rata for part-time staff. PLUS 8 bank holidays
• Privilege Leave: 1 day
• Hours of Work: 37 hours (net) per week for full time staff in all geographical locations, including London and pro rata for part-time staff
• Occupational Sick Pay (OSP): One month full pay/one month half pay on entry, rising by one month for each completed year of service to a maximum of six months full pay and six months half pay after five years’ service.
• Mobility: Mobility clause in contracts allowing staff to be mobile across the Civil Service
• Civil Service Pension Scheme. Please see the link for further information http://www.civilservicepensionscheme.org.uk/ For enquiries relating to the Civil Service Pension Schemes please contact MyCSP's Pension Service Centre directly on 0300 123 6666
• Flexible working to ensure staff maintain a healthy work-life balance
• Interest free season ticket loan or bike loan
• Employee Assistance Services and access to the Civil Service Benevolent Fund
• Eligibility to join Motoring , Boundless by CSMA
• Variety of staff and Civil Service clubs
• On-going learning and development

Things you need to know

Artificial intelligence

Artificial intelligence can be a useful tool to support your application, however, all examples and statements provided must be truthful, factually accurate and taken directly from your own experience. Where plagiarism has been identified (presenting the ideas and experiences of others, or generated by artificial intelligence, as your own) applications may be withdrawn and internal candidates may be subject to disciplinary action. Please see our candidate guidance (opens in a new window) for more information on appropriate and inappropriate use.

Selection process details

This vacancy is using Success Profiles (opens in a new window), and will assess your Behaviours, Strengths, Experience and Technical skills.

Key dates

• Closing date 09 November 2026
• Sifting – From 10 November 2026
• Main panel interviews – From w/c 30 November 2026

Communications will be electronic via email therefore it is important that you check your Civil Service Jobs account regularly, as well as your spam/junk email folder.

We’re committed to being diverse and inclusive, so please make your application anonymous by removing all identifying personal information (such as names and dates) from your employment history and personal statement.

What will the process look like?

1. Pre-sift Stage

An initial sift will be conducted on the experience question which has a word limit of 500 words. If you are assessed as not meeting the required level, you will not be progressed past this stage.

Question: "Please describe your experience of advising on regulatory affairs, regulatory policy or regulatory science relating to artificial intelligence, machine learning, non-clinical development, toxicology, pharmacology or other emerging technologies." (maximum 500 words).

2. Sift Stage

The main sift, where we'll read and score the rest of your application. This may involve a large number of applications, please bear with us as this can take some time.

• Anonymised CV which sets out your career history, previous experience and skills, highlighting specific responsibilities that are relevant for this role.
• Online application form, including questions based on the Behaviour, Experience and Technical Success Profiles. Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank.

The panel will look at your application and are looking for evidence of the stated points. We may raise the benchmark score required if we receive a high number of applications.

3. Main Panel Interview

Successful candidates from the sift stage will be invited to attend an interview. We use a blended interview technique, allowing us to find out more about you. We use the Success Profile framework and at interview we will be assessing Behaviours and Experience.

Your interview will include:

• Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage.

At interview, we will be asking questions relating to the following:

• Behaviours, as listed in the person specification
• Experience, as listed in the person specification
• Strengths

If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible.

Candidates will be subject to UK immigration requirements as well as Civil Service nationality rules. Further information on whether you are able to apply is available here.

Successful candidates must pass a disclosure and barring security check as well as animal rights and pro-life activism checks. People working with government assets must complete basic personnel security standard checks.

Certain roles within the MHRA will require post holders to have vaccinations, and in some circumstances, routine health surveillance. These roles include:

• Laboratory-based roles working directly with known pathogens
• Maintenance roles, particularly those required to work in laboratory settings
• Roles that involve visiting other establishments where vaccination is required
• Roles required to travel overseas where specific vaccination may be required.

Applicants who are successful at interview will be, as part of pre-employment screening subject to a check on the Internal Fraud Database (IFD). This check will provide information about employees who have been dismissed for fraud or dishonesty offences. This check also applies to employees who resign or otherwise leave before being dismissed for fraud or dishonesty had their employment continued. Any applicant’s details held on the IFD will be refused employment. A candidate is not eligible to apply for a role within the Civil Service if the application is made within a 5 year period following a dismissal for carrying out internal fraud against government.

Any move to the MHRA from another employer will mean you can no longer access childcare vouchers. This includes moves between government departments. You may however be eligible for other government schemes, including Tax-Free Childcare. Determine your eligibility here.

Individuals appointed on level transfer will retain their existing salary and are responsible for ensuring they fully understand the financial implications of any potential move and the impact (if any) on their terms. If an individual is in any doubt, they should seek clarification before accepting a job offer.

Staff joining on promotion will receive up to a 10% increase of their current basic salary, or the pay band minimum, whichever is the greater.

The individual will not retain any allowances paid by the former department/Agency, unless there are special circumstances, such as a reserved right to those allowances on transfer.

Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries, please contact careers@mhra.gov.uk.

Feedback will only be provided if you attend an interview or assessment.

Security

Successful candidates must undergo a basic (or equivalent) criminal record check.People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Nationality requirements

This job is broadly open to the following groups:

• UK nationals
• nationals of the Republic of Ireland
• nationals of Commonwealth countries who have the right to work in the UK
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) (opens in a new window)
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
• Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service

Further information on nationality requirements (opens in a new window)

Working for the Civil Service

The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.

We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window).The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.

Diversity and Inclusion

The Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see theCivil Service People Plan (opens in a new window) and the Civil Service Diversity and Inclusion Strategy (opens in a new window).

Apply and further information

This vacancy is part of the Great Place to Work for Veterans (opens in a new window) initiative.Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.

Contact point for applicants

Job contact :

• Name : The Resourcing Team
• Email : Careers@mhra.gov.uk

Recruitment team

• Email : Careers@mhra.gov.uk

Further information

In accordance with the Civil Service Commissioners’ Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointment on the basis of merit by a fair and open competition. If you feel your application has not been treated in accordance with the Recruitment Principles and you wish to make a complaint, you should contact the Resourcing team at Careers@mhra.gov.uk, in the first instance. If you are not satisfied with the response you receive you can contact the Civil Service Commission at: civilservicecommission.independent.gov.uk - info@csc.gov.uk - Civil Service Commission Room G/8 1 Horse Guards Road London SW1A 2HQ

Attachments

JD Regulation & Policy Lead, AI for Medicines Safety NS Opens in new window (pdf, 167kB)