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

10 South Colonnade, Canary Wharf London, E14 4PU.

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

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.

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

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?

• 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.

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