Pharmaceutical Assessor at Medicines and Healthcare Regulatory Agency

London, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

28 Dec, 25

Salary

0.0

Posted On

29 Sep, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Skills, Communication, Decision Making, Collaboration, Risk Assessment, Technical Expertise, Regulatory Knowledge, Data Interpretation

Industry

Government Administration

Description

We are currently looking for a Pharmaceutical Assessor to join our Population Health Function within the Healthcare, Quality and 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. 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 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 Population Health function delivers a risk appropriate critical appraisal of quality, safety and efficacy of healthcare products that are critical to the NHS and wider population, determining whether a product’s benefits outweigh the risks. This includes work on special populations, self-medication and unlicensed imports, authorisations and variations for generic medicines, other complimentary products as well as parallel import medicines. This enables access while ultimately reducing costs to the healthcare system and delivering positive patient benefits as a result. What’s the role? The Parallel Import Unit is responsible for all licensing activities relating to the importation of medicinal products from countries within the European Economic Area under the parallel import licensing scheme. There is a need to obtain and critically assess information from international data sources to ensure parallel import licences are granted in accordance with legislative requirements and safeguard public health. The post holder will take a leading role in collaboration with the administrative team, conducting initial triage assessments to determine the feasibility and safety of licence applications. These considerations will follow a risk-based methodology. In addition, the post holder will perform assessment of new parallel import licence applications - focussing particularly on new products and new sources – as well as assessing pharmaceutical variation applications. They will also serve as the technical lead for the processing of renewal applications for existing parallel import licences. Key responsibilities: Assessment of new product, new source and existing source initial applications for parallel import licences, including confirmation of the therapeutic equivalence of the UK and imported product and evaluation of proposed labels and leaflets. Assessment of pharmaceutical variations including updates to patient information leaflets and labelling. Triage parallel import applications by sourcing and analytically interpreting information on the imported product. Make risk-based decisions on acceptability of parallel import applications and communicate with applicant companies, as necessary. Preparation of assessment reports for applications, ensuring all points comply with parallel import scheme guidelines. Maintenance of MHRA information systems with complete and auditable records of the assessment process. Consultation with internal and external expertise as required. Update Standard Operating Procedures and provide associated training as appropriate. Work collaboratively with other assessors and management to address technical issues arising from assessment of medicines. Provide advice and guidance internally and to external stakeholders. Lead on the processing of Renewal applications resolving technical issues, as necessary. Meeting agreed business and assessment targets. Develop processes to associate parallel import licences with international recognition reliance procedures. Who are we looking for? Our successful candidate will demonstrate the following. Making Effective Decisions Communicating and Influencing Seeing the Bigger Picture Working Together Experience and proven ability to analyse and interpret complex data and make appropriate recommendations or decisions to protect public health. If you would like to find out more about this fantastic opportunity, please read our Job Description and Person Specification! Please note: The job description may not open in some internet browsers. Please use Chrome or Microsoft Edge. If you have any issue viewing the job description, please contact careers@mhra.gov.uk The selection process: We use the Civil Service Success Profiles to assess our candidates, find out more here. 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. 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 candidates having knowledge of the parallel import scheme and experience of assessing parallel import new applications and variations. 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 allow sufficient time. You can view the competencies for this role in the job description. Use of AI in Job Applications Applicants must ensure that anything submitted is factually accurate and truthful. Plagiarism can include presenting the ideas and experience of others, or generated by artificial intelligence, as your own. 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: 13th October 2025 Shortlisting date: from 21st October 2025 Interview date: from 6th November 2025 Candidates will be contacted within a week of the sift and the interviews completed to inform them of the outcome. If you need assistance applying for this role or have any other questions, please contact careers@mhra.gov.uk 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. 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. 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. 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 firstly contact Florentina Oleylami, Head of Talent Acquisition, Florentina.Oyelami@mhra.gov.uk. 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

Responsibilities

The Pharmaceutical Assessor will assess new and existing parallel import licence applications, ensuring compliance with legislative requirements. They will also conduct triage assessments and prepare detailed reports on applications.