Quality Assessor

We are currently looking for a Quality Assessortoassess drug substance data submitted in active substance master files (ASMFs) and in new (innovative) drug product applications to join ourOperational DeliveryFunction within theHealthcare Quality and Accessgroup.

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.We are open to requests for flexible working. Please discuss this with the recruiting manager before accepting an appointment.

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 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.

Whats the role

Reporting to one of the Heads of Team in Established Medicines the role encompasses a broad range of activities from assessing drug substance data for a new active substance to assessing ASMFs submitted with new and variation applications to providing scientific advice to companies around pharmaceutical/regulatory issues for drug substances.

Key responsibilities:

• Carry out the assessment of drug substance data provided in submissions for initial and variation marketing authorisation applications for chemical 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

• Extend and deepen skills and knowledge in relevant scientific or professional areas

• Contribute to assessment policy and practice and proactively identify where such contributions would be beneficial.

Who are we looking for

Oursuccessful candidatewill demonstrate the following.

• Hold a degree in pharmacy pharmaceutical chemistry or chemistry with relevant postgraduate experience or PhD equivalent. Full degree titles should be included.

• In depth experience specialist level of knowledge in the manufacture and control of chemical drug substances

• The ability to critically analyse scientific information from a range of sources and make sound judgements for medicines in line with public health needs.

• Excellent written and verbal communication skills. Ability to write authoritative reports and convey information through effective verbal communication and presentational skills appropriate to the target audience.

• Knowledge of relevant legislation and procedures applicable to the licensing of human medicinal products.

Person Specification:

Method of assessment:AApplication IInterview

Behaviour Criteria:

• Delivering at Pace (A I)

• Communicating and Influencing (A I)

• Managing a Quality Service (A I)

Experience Criteria:

• Relevant work experience and knowledge relating to the manufacture and control of chemical drug substances. (A I)

• Ability to critically analyse scientific information from a range of sources and make sound judgements for medicines in line with public health needs.(A I)

Technical Criteria:

• In depth specialist level of knowledge in the manufacture and control of chemical drug substances (A I)

• Hold a degree in pharmacy pharmaceutical chemistry or chemistry (please include full degree title) with relevant postgraduate experience or PhD equivalent.(A I)

• Knowledge of relevant guidelines related to the manufacture and control of drug substances and the regulations and procedures for marketing authorisations and/or ability to acquire such knowledge quickly. (A I)

If you would like to find out more about this opportunity please readour 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 including questions based on AbilityBehaviour Experience and Technical Success Profiles.Please ensure all application questions are completed in full and please include full degree titles with your application; 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.

• 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 havingin depth specialist level of knowledge in the manufacture and control of chemical drug substances along with relevant work experience or PhD equivalent. Please note that candidates who do not hold adegree in pharmacy pharmaceutical chemistry or chemistry will not be considered further.

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 ourcandidate guidancefor 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:10^th April 2026

Shortlisting date: from 27 April 2026

Interview date:from 18 May 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.

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.

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.

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