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

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

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

We'll assess you against these behaviours during the selection process:

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

Technical skills

We'll assess you against these technical skills during the selection process:

• 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 (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

Things you need to know

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.

Key dates

• 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?

1. 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.

2. 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 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.

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 careers@mhra.gov.uk.

Feedback will only be provided if you attend an interview or assessment.

Security

Successful candidates must undergo a basic (or equivalent) criminal record check.People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Nationality requirements

This job is broadly open to the following groups:

• UK nationals
• nationals of the Republic of Ireland
• nationals of Commonwealth countries who have the right to work in the UK
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities with settled or pre-settled status under the European Union Settlement Scheme (EUSS) (opens in a new window)
• nationals of the EU, Switzerland, Norway, Iceland or Liechtenstein and family members of those nationalities who have made a valid application for settled or pre-settled status under the European Union Settlement Scheme (EUSS)
• individuals with limited leave to remain or indefinite leave to remain who were eligible to apply for EUSS on or before 31 December 2020
• Turkish nationals, and certain family members of Turkish nationals, who have accrued the right to work in the Civil Service

Further information on nationality requirements (opens in a new window)

Working for the Civil Service

The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.

We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window).The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria.The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.

Diversity and Inclusion

The Civil Service is committed to attract, retain and invest in talent wherever it is found. To learn more please see theCivil Service People Plan (opens in a new window) and the Civil Service Diversity and Inclusion Strategy (opens in a new window).

Apply and further information

This vacancy is part of the Great Place to Work for Veterans (opens in a new window) initiative.Once this job has closed, the job advert will no longer be available. You may want to save a copy for your records.

Contact point for applicants

Job contact :

• Name : The Resourcing Team
• Email : Careers@mhra.gov.uk

Recruitment team

• Email : Careers@mhra.gov.uk

Further information

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 contact the Resourcing team at Careers@mhra.gov.uk, in the first instance. 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