Medicines and Healthcare products Regulatory Agency
Non-Clinical Assessor (Biological) - £60,778 – 68,422 p.a. + benefits
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10 South Colonnade, Canary Wharf London, E14 4PU.
Job Summary
We are currently looking for a Non-Clinical Assessor (Biological) to join our Innovative Medicines Function within the Healthcare and Quality Access 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.
The objective of the Healthcare Quality and Access 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 function delivers a risk appropriate critical appraisal of quality, safety and efficacy of innovative medicinal products, determining whether a product’s benefits outweighs the risks. It aims to accelerate their route to market to drive earlier patient access. Through this function the Agency will be seen as a leader in facilitating early access to safe and innovative medicines attracting the life sciences sector and contributing to a positive patient experience and to the improvement of public health outcomes.
Job Description
Reporting to the Head of Biologicals team, a Non-clinical Assessor (Biologicals) evaluates the pre-clinical and environmental risk aspects of marketing authorisation, Early Access to Medicines (EAMs), Innovative Licensing and Access Pathway (ILAP) and clinical trial applications for medicinal products and make decisions on their suitability for approval.
This role encompasses the evaluation of a range of new biological medicinal products, including new active substances, advanced therapies, and other innovative products at different stages of development, as well as their environmental impact. The role also contributes to the development of regulatory policy, scientific guidance, and legislative frameworks relating to innovative medicinal products and emerging technologies. The reports written and recommendations made will be highly influential in initiating trials of new medicines and taking these through clinical development, and/or allowing new medicines to be made widely available to patients.
The post offers career development and progression opportunities in line with our internal development programme (scheme structure currently under review).
Key Responsibilities
Service delivery
- Carry out the assessment of pre-clinical data provided in marketing authorisation and clinical trial authorisation applications for biological products, making appropriate recommendations and decisions in line with the protection of public health.
- Involvement in the ILAP and EAMs scheme, and provision of scientific advice on the non-clinical aspects and/or environmental aspects of drug development.
- Contribute to the drafting, review, implementation, and other cross-functional activities associated with development of legislation, scientific guidance, and policy documents relating to medicinal products and emerging technologies.
- Manage own workload, working in conjunction with other assessors to meet agency deadlines.
- Prepare and present objective assessments or other scientific papers to expert advisory bodies.
Service improvement
- Contribute to development of assessment policy, regulatory guidance, legislative implementation, and scientific practice; and proactively identify where such contributions would be beneficial.
- Contribute to divisional procedures and proactively identify where such contributions would be beneficial.
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Quality and Assurance
- Promptly update agency, divisional or team work management databases to reflect the progress of own’s 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 divisional strategy to meet targets
- Support the generation and evaluation of evidence from internal and external sources to inform decision making, policy development, and continuous improvement.
Leadership and management
- Lead or contribute to multidisciplinary projects involving internal and external stakeholders to support regulatory, scientific and policy objectives.
- Develop to provide ad hoc advice to colleagues in the Division or Agency.
- Extend and deepen skills and knowledge in relevant scientific or professional areas.
General
- Develop good working relationships and communicate effectively with colleagues and other internal and external stakeholders, including government departments, healthcare organisations, academia, industry and patient representatives.
- Participate in other ad-hoc tasks/projects as requested by the Unit Manager.
The job description is not intended to be exhaustive and it is likely that responsibilities and outcomes may be altered from time to time in the light of changing circumstances and after consultation with the postholder.
Person specification
Essential Criteria:
- Previous experience in one or more of the following: pre-clinical aspects of drug development, translational science, medicines regulation or regulatory policy, ecotoxicology or environmental regulatory affairs, within the pharmaceutical industry, governmental departments or academia.
- Experience with data analysis particularly with Biological products, with gene therapy experience being an advantage.
- Experience contributing to the development, interpretation or implementation of regulatory policy, guidance or regulatory frameworks relevant to medicinal products.
- Experience working collaboratively with a broad range of stakeholders, including government bodies, healthcare organisations, academia, industry and patient groups.
Qualifications
- Degree in molecular biology, toxicology, pharmacology, immunology or other appropriate life science.
Behaviours
We'll assess you against these behaviours during the selection process:
- Delivering at Pace
- Communicating and Influencing
- Managing a Quality Service
- Making Effective Decisions
Technical skills
We'll assess you against these technical skills during the selection process:
- Up to date specialist knowledge in one or more relevant scientific areas or broader knowledge across scientific activities in relation to the non-clinical development of human medicinal products, including biological products, & advanced therapies.
- Sound knowledge of relevant legislation and procedures applicable to the licensing of human medicinal products.
Benefits
Alongside your salary of £60,778, Medicines and Healthcare Products Regulatory Agency contributes £17,607 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
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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.
- 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.
- Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage.
- Interview, which can include questions based on the Behaviour, Experience, Technical and Strengths Success Profiles.
- An anonymised CV outlining your job history and previous skills/experience that demonstrate how you meet the essential criteria.
In the instance that we receive a high number of applications, we will hold an initial sift based on the lead criteria of: Up to date specialist level of knowledge in one or more relevant scientific areas or broader knowledge across the range of scientific activities in relation to the non-clinical development of human medicinal products, including biological products, and advanced therapies.
If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible.
Closing date: 25 September 2026
Shortlisting date: From 26 September 2026
Interview date: From 05 October 2026
If you need assistance applying for this role or have any other questions, please contact careers@mhra.gov.uk
Candidate requirements
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
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