Quality Assessor

We are currently looking for aQuality Assessor to join ourInnovative Medicines Team Function within theHealth Quality and AccessAccessgroup.

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.

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 objective of the Healthcare Quality and Access (HQA) portfolio is to drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways. It will do this by bringing together a fusion of our capabilities across both medicines and medical devices to enable licensing and market access, as well as ensuring compliance with regulations and standards

The Innovative Medicines - Unlicensed Medicine function, part of HQA, delivers a risk-based appraisal of Unlicensed medicines and whether they may or may not be supplied within the UK, to safeguard public health. It enables wider access to these important medicines when licensed medicines are not available to meet the needs of individual patients.

What's the role? Quality Assessors form part of multidisciplinary teams and will specifically assess the quality aspects of initial applications for the marketing authorisation (MA) of biological medicinal products and subsequent variations to existing MAs.

They are responsible for providing scientific and regulatory advice to internal and external stakeholders, supporting UK healthcare innovation of biological medicinal products. Assessors will also be expected to participate in non-assessment activities such as maintaining and developing regulatory and scientific guidance and engaging with stakeholders to deliver wider agency goals.

Key responsibilities:

• Carry out the assessment of data provided in initial and variation marketing authorisation applications for biological products, making appropriate recommendations and decisions in line with the protection of public health.
• Prepare and present objective risk-based assessments or other scientific papers to expert advisory bodies.
• Manage own workload, working in conjunction with managers, support staff and other assessors to meet agency deadlines.
• Display a high level of attention to detail to ensure up to date accurate data and documents are held on internal databases.
• Develop good working relationships and communicate effectively with colleagues and other internal and external stakeholders.

Who are we looking for? Oursuccessful candidatewill demonstrate the following:

• Degree and postgraduate degree in a relevant biological science, such as biochemistry, molecular biology, immunology, cell biology, pharmacy. PhD or equivalent experience is preferred.
• In depth experience in:regulatory affairs, research and development,manufactureor quality control of biological medicinal products within the pharmaceutical/biotechnology industry or academia (or equivalent).
• Up to date, detailed,specialist level of knowledge in one or more relevant scientific areasandbroader knowledge across the range of scientific activities in relation to the pharmaceutical development, manufacture, and quality control ofbiologicalmedicinal products.
• Experience communicating technical information accurately and effectively to relevant partiesevidencingexcellent written and verbal communication skills.
• Working Together

Person Specification: Method of assessment: A=Application, T=Test, I=Interview, P=Presentation Behaviour Criteria:

• Making Effective Decisions (A,I)
• Working Together (A,I)
• Managing a quality Service (A,I)

Experience Criteria:

• Ability to handle throughput of workcommensuratewith experience and knowledge to meet required deadlines.(A,I)
• In depth experience in: regulatory affairs, research and development,manufactureor quality control of biological medicinal products within the pharmaceutical/biotechnology industry or academia (or equivalent).(A,I)
• Demonstrable experience of developing successful relationships with both internal and external stakeholders, with excellent communication skills.(A,I)
• Experience communicating technical information accurately and effectively to relevant partiesevidencingexcellent written and verbal communication skills.(A,I)

Technical Criteria:

• Degreeand postgraduate degreein a relevant biological science,such asbiochemistry,molecular biology,immunology, cell biology, pharmacy.PhDor equivalent experience is preferred.(A)
• Up to date, detailed,specialist level of knowledge in one or more relevant scientific areasandbroader knowledge across the range of scientific activities in relation to the pharmaceutical development, manufacture, and quality control ofbiologicalmedicinal products. (A,I,T)
• Keen attention to detail, a proven ability to apply critical thinking to complex problems.(A,I,T)

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The selection process: We use the Civil Service Success Profiles to assess our candidates.

• 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. Our applications are CV blind, and our Hiring Managers will not be able to access your CV when reviewing your application.
• Test, further information will be supplied when you reach this stage
• Interview, which can include questions based on the Behaviour, 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:

• Degreeand postgraduate degreein a relevant biological science,such asbiochemistry,molecular biology,immunology, cell biology, pharmacy.PhDor equivalent experience is preferred.
• In depth experience in: regulatory affairs, research and development,manufactureor quality control of biological medicinal products within the pharmaceutical/biotechnology industry or academia (or equivalent).

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.

Use of AI in Job Applications 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 for more information on appropriate and inappropriate use.

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

Closing date:31st July 2026

Shortlisting date: from 10th August 2026

Interview date:from 2nd September 2026

If you need assistance applying for this role or have any other questions, please contact

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) . click apply for full job details