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profile Job Location:

London - UK

profile Monthly Salary: Not Disclosed
Posted on: 30+ days ago
Vacancies: 1 Vacancy

Job Summary

Description

This is a full-time opportunity on a permanent promotionbasis. 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 Unit/Team Leaders in Population Healththe role involves the assessment of variations where Northern Ireland (NI) is a Concerned Member State (CMS).The post holder will be expected to progress the variations on our MHRA database Sentinel with responsibility for maintaining the integrity and accuracy of the relevant case folders.

Liaising with other personnel to obtain relevant documentation or resolve concurrencies the post offers the opportunity to work within a multi-disciplinary project team and to play a key role in achieving the wider Agency targets.

  • Ensure that regulatory guidelines are followed in checking the validity of applications received.
  • Work closely with relevant personnel to retrieve relevant End of Procedure (EoP) documentation and upload these to the relevant Case Folder.

  • Provide support to assessors as appropriate.

Key responsibilities:

  • To assess Type 1B and Type II CMS and other allocated national variations

  • Liaise with relevant quality assessors and/or designated contacts across the Agency as appropriate to ensure that all concurrencies are accurately resolved subject to granting the relevant variation.

  • Proactively identify variations that may need additional input from quality assessors across Population Health and flag as appropriate.

  • Take responsibility for setting accurate steps throughout the assessment procedure and maintaining the integrity of the Case Folder and the Current Granted View.

Who are we looking for

Oursuccessful candidatewill demonstrate the following.

  • Graduate with a Life Sciences degree with extensive experience of the information management of regulatory submissions

  • Previous experience of assessing variation applications

  • Ability to analyse and interpret scientific data with potential to identify discrepancies errors or potential serious risks to public health concerns

  • Ability to resolve concurrencies encountered in the processing of variation applications

  • Good organisational skills and ability to prioritise work to meet tight deadlines whilst maintaining high standards of quality to deliver multiple tasks on time with a low level of supervision.

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

The selection process:

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

  • Online application form including questions based on theBehaviour 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 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 having a Life Sciences degree and extensive experience of the information management of regulatory submissions.

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

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 as soon as possible.

Closing date:12th October 2025

Shortlisting date: from 20th October 2025

Interview date:from 27th October 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 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.

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



DescriptionThis is a full-time opportunity on a permanent promotionbasis. 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 ...
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About Company

About Us 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 agency is made up of c.1300 staff working across ... View more

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