Assessor Non Clinical

We are currently looking for aNon-clinical Assessor to join our Clinical Investigations and Trials Function within the Science Research and Innovation 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. Please be aware that this role can only be worked in the UK and not overseas.

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.

Who are we

The Medicines and Healthcare products Regulatory Agency enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices underpinned by science and research.

The Innovation and Compliance Group delivers public health impact world-leading research innovation and a unique proposition via an ambitious Science Strategy which will balance innovation against sustainability and affordability. It is divided into 3 sub-Groups Innovation Accelerator and Regulatory Science Clinical Investigations and Trials and Standards and Compliance.

Whats the role

The clinical investigations and trials function ensure the efficient pragmatic proportionate and patient-centred advice for and assessment of clinical investigations into the performance and safety of medical devices and diagnostics as well clinical trials of investigational medicinal products.

Non-clinical Assessors assess the pre-clinical aspects of clinical trial applications for medicinal products and take decisions on their suitability for approval.

The role encompasses a broad range of activities from assessing an application for a new chemical or biological active substance to providing scientific advice to companies around non-clinical / regulatory issues for development of new drug products.

A comprehensive training programme is in place to support and further develop candidates with previous assessment experience.

Key responsibilities:

• Working independently carry out the risk-based assessment of data provided in clinical trial authorisation initial and amendment applications for chemical biological or advanced therapy products making appropriate recommendations and decisions in line with the protection of public health. Prepare and present objective assessment reports or other scientific papers to expert advisory bodies.
• Manage own workload working in conjunction with the support team and other assessors to meet agency deadlines.
• Promptly update agency- group- and unit-level management databases to reflect the progress of own work. Display a high level of attention to detail to ensure up to date accurate data and documents are held on internal databases. Use own and agency resources in line with agency and group strategy to meet targets.

• Develop good working relationships and communicate effectively with colleagues and other internal and external stakeholders. Participate in other ad-hoc tasks/projects as requested by managers.

Who are we looking for

Oursuccessful candidatewill demonstrate the following.

• Managing a Quality Service: Ability to handle throughput of work commensurate with experience and knowledge to meet required deadlines while maintaining adherence to legal and regulatory requirements.
• Delivering at Pace: Flexibility to adapt to changing priorities and take responsibility for achieving a successful outcome.
• Evidence of effective decision making including clear communication of the purpose and reasons for recommendations and decisions internally and to external experts.
• Previous experience in at least one of the following regulatory affairs toxicology or pharmacology within academia governmental departments or the pharmaceutical industry.
• Degree in toxicology or other appropriate life science with relevant postgraduate experience or PhD.

Person Specification:

Method of assessment:AApplication TTest IInterview PPresentation

Behaviour Criteria:

• Communicating and Influencing (A I)
• Managing a Quality Service (A I)
• Delivering at Pace(A I)

Experience Criteria:

• Evidence of effective decision making including clear communication of the purpose and reasons for recommendations and decisions internally and to external experts.(A I)
• Previous experience in at least one of the following regulatory affairs toxicology or pharmacology within academia governmental departments or the pharmaceutical industry. (A I)

Technical Criteria:

• Degree in toxicology or other appropriate life science with relevant postgraduate experience or PhD (or equivalent).(A)

• Up to date specialist level of knowledge in one or more relevant scientific area or broader knowledge across the range of scientific activities in relation to the non-clinical development of human medicinal products. Knowledge of relevant legislation and procedures applicable to the regulation of clinical trials.(A I)

Strengths Criteria

• Relationship Builder (I)

• Team Player (I)

If you would like to find out more about this fantastic opportunity please read our Job Description and Person Specification!

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The selection process:

We use the Civil Service Success Profiles to assess our candidatesfind out more here.

• Online application form an application questionof no more than 750words demonstrating how you meet the person specification and key responsibilities as outlined in the advert.Please ensure all application questions are completed in full; your application may not be considered if any responses are left blank.All information that you provide will be anonymised and our Hiring Managers will not be able to access your details when reviewing your application.Please ensure not to include any personal identifying information on your supporting information

• Interview which can include questions based on theBehaviour Experience Technical and Strengths Success Profiles.

In the instance that we receive a high number of applications we will hold an initial sift based on the lead criteria of candidates demonstratingup to date specialist level of knowledge in one or more relevant scientific area or broader knowledge across the range of scientific activities in relation to the non-clinical development of human medicinal products. Knowledge of relevant legislation and procedures applicable to the regulation of clinical trials.

Applicants are assessed on whether they meet any mandatory requirements as well as the necessary skills and experience for the role. Applications are scored based on the competency-based answers provided- ensure you have read these thoroughly and allowsufficienttime. You can view the competencies for this role in the job description.

If you require any disability related adjustments at any point during the process please contact as soon as possible.

Closing date:7^th December 2025

Shortlisting date: from 8^th December 2025

Interview date:from 5^th January 2026

If you need assistance applying for this role or have any other questionsplease contact

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

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 completebasic 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 applicants 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 eligibilityhere.

Successful candidates may be subject to annual Occupational Health reviews dependent on role requirements. If you have any queries please contact.

In accordance with the Civil Service Commissioners Recruitment Principles our recruitment and selection processes are underpinned by the requirement of selection for appointmenton the basis ofmerit 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 firstly contact Florentina OleylamiHead of Talent Acquisition.

If you are not satisfied with the response you receive you can contact the Civil Service Commission at:

Civil Service Commission

Room G/8

1Horse Guards Road

London

SW1A 2HQ