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Medicines and Healthcare products Regulatory Agency

Regulatory Strategy Specialist - £75,585 - £84,840 p.a. +benefits

London
£75.5k – £84.9k/yr
Posted 1 day ago
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Regulatory Strategy Specialist

Job Summary

We are currently looking for a Regulatory Strategy Specialist to join our National Licensing Strategy Function within the Healthcare 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. 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. Remote working is potentially available for some specific roles. Please discuss this with the recruiting manager before accepting an appointment.

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 Licensing Strategy function delivers guidance, policy and strategic initiatives to develop innovative pathways for medicines in the UK and position the UK as an attractive location for market authorisations. Through this function the Agency will be seen as a leader in facilitating early access to safe and innovative medicines, furthering the attractiveness of the life sciences sector and contributing to a positive patient experience and to the improvement of public health outcomes.

Job Description

Role Purpose

This role encompasses the support of regulatory projects, relevant to the UK’s licensing strategy which will benefit UK patients and the economy. The regulatory strategy specialist will lead and develop a series of outputs, including projects and recommendations which are critical to the MHRA’s licensing activities.

Key Responsibilities

Leadership and management

  • Develop and provide advice to colleagues in the Division or Agency
  • Extend and deepen skills and knowledge in relevant scientific or professional areas

Service delivery

  • Carry out research and analysis on UK and international regulation, guidance and policy, making appropriate recommendations and decisions in line with the protection of public health.
  • Involvement in multiple Licensing pathways (ILAP, IRP, etc) and development of UK licensing guidance and legislation.
  • Manage own workload working in conjunction with function to meet agency deadlines
  • Prepare and present recommendations, research and guidance to internal working groups and leaders

Service Improvement

  • Contribute to MHRA policy and practice and proactively identify where such contributions would be beneficial
  • Contribute to divisional procedures and proactively identify where such contributions would be beneficial

Quality and Assurance

  • Promptly update agency, divisional or team, work management databases to reflect the progress of own 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

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General

  • Develop good working relationships and communicate effectively with colleagues and other internal and external stakeholders
  • Participate in other ad-hoc tasks/projects as requested by the Unit Manager

Person specification

Essential Criteria

  • Substantial experience in at least one of the following:
    • Pharmaceutical industry
    • Governmental departments
    • Academia

Qualifications

  • Pharmacy or biological science degree, with knowledge of relevant legislation and procedures applicable in the licensing of human medicinal products

Behaviours

  • Delivering at Pace
  • Communicating and Influencing
  • Managing a Quality Service

Technical skills

  • Pharmacy or biological science degree, with knowledge of relevant legislation and procedures applicable in the licensing of human medicinal products.
  • Working knowledge of relevant legislation and procedures applicable to the licensing of human medicinal products.

Benefits

Alongside your salary of £75,585, Medicines and Healthcare Products Regulatory Agency contributes £21,896 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.

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

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 for more information on appropriate and inappropriate use.

Selection process details

This vacancy is using Success Profiles, and will assess your Behaviours, Strengths, Experience and Technical skills.

Key dates

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  • Closing date: 12 October 2026 at 23:55
  • Sifting: from 13 October 2026
  • Main panel interviews: From w/c 26 October 2026

Communications will be electronic via email therefore it is important that you check your Civil Service Jobs account regularly, as well as your spam/junk email folder.

We’re committed to being diverse and inclusive, so please make your application anonymous by removing all identifying personal information (such as names and dates) from your employment history and personal statement.

What will the process look like?

Sift Stage

The main sift, where we'll read and score the rest of your application. This may involve a large number of applications, please bear with us as this can take some time.

  • Anonymised CV which sets out your career history, previous experience and skills, highlighting specific responsibilities that are relevant for this role.
  • Personal statement: Write a 750 word personal statement where you demonstrate how you meet the skills required for this role, providing examples to evidence your level of skill. In your personal statement we are looking for evidence of how you meet the role criteria and person specification. Your personal statement should aim to make use of the full wordcount and show how you meet the above criteria. Please give clear and specific examples of what you have done personally and the impact it has had.
  • 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.

The panel will look at your application and are looking for evidence of the stated points. We may raise the benchmark score required if we receive a high number of applications.

Main Panel Interview

Successful candidates from the sift stage will be invited to attend an interview. We use a blended interview technique, allowing us to find out more about you. We use the Success Profile framework and at interview we will be assessing Behaviours and Experience.

At interview, we will be asking questions relating to the following:

  • Behaviours, as listed in the person specification
  • Experience, as listed in the person specification
  • Strengths

Feedback will only be provided if you attend an interview.

If you require any disability related adjustments at any point during the process, please contact careers@mhra.gov.uk as soon as possible.

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

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Location

London, England, United Kingdom

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