Deputy Director, Scientific Advice at Medicines and Healthcare Regulatory Agency

London, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

25 May, 26

Salary

0.0

Posted On

24 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Strategic Leadership, Service Build-out, Regulatory Advice, Quality Assurance, Stakeholder Engagement, Cross-functional Assessment, Regulatory Science, Drug Development, Device Development, Team Leadership, Capacity Building, Critical Appraisal, Risk Assessment, Policy Analysis, Service Culture

Industry

Government Administration

Description

Who are we? 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 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. What’s the role? As Deputy Director, Scientific Advice, this role will lead the establishment and development of a Scientific Advice Service embedded in MHRA provide high-quality scientific and regulatory advice to external stakeholders (industry, academia, SMEs, device- and drug-developers) to support licensing, market access, and safe, effective patient access to medicines and medical devices in the UK. The post-holder will ensure the service aligns with MHRA’s mission to enable healthcare access while upholding quality, safety, and regulatory standards. Key responsibilities: Strategic Leadership & Service Build-out Design and implement the operational model for the Scientific Advice Service: define scope (medicines, devices, biologics/ATMPs, etc.), standard operating procedures (SOPs), request/response flows, quality-assurance processes, internal governance structure, and resource allocation. Ensure the Scientific Advice Service supports HQ&A’s objectives: licensing, market access, regulatory/quality evaluation, accelerated-access pathways, and compliance with regulatory standards. (HQ&A’s mission is to “drive quality and critically appraise benefits and risks to inform robust decisions on healthcare access including accelerated access pathways.”) Monitor and react to evolving scientific, regulatory and policy landscapes — including new product types (e.g. advanced therapies, combination products), novel modalities, and innovation — adjusting advice frameworks accordingly. Oversight of Scientific / Regulatory Advice Delivery Oversee delivery of scientific and regulatory advice across key domains: quality, non-clinical, clinical development, regulatory strategy, lifecycle management, device/medicines interface. Quality-assure advice outputs: ensure consistency, scientific rigour, alignment with regulatory standards and HQ&A’s public-health mandate. For complex or novel cases (e.g. biologics, ATMPs, combination products, device–drug interfaces), provide senior-level guidance or lead cross-functional assessment. Stakeholder Engagement & External Collaboration Act as senior point-of-contact with external stakeholders (pharma/ biotech companies, device-makers, academic developers, SMEs) seeking scientific/regulatory advice. Represent MHRA (HQ&A) in external forums — industry consultations, regulatory-science networks, cross-agency collaborations (national/international), and where appropriate, early-access or innovative access initiatives. Lead or coordinate scientific-advice meetings (pre-submission, protocol-assistance, regulatory pathway planning) and ensure transparent, consistent communication. Integration with HQ&A and MHRA Corporate Strategy Work closely with other HQ&A functions (e.g. licensing, market-access, quality assessment, accelerated access pathways) to ensure Scientific Advice Service is integrated in the agency’s regulatory and access workflow. Contribute to HQ&A and broader MHRA strategic objectives: enabling safe, timely access to medical products, supporting innovation, ensuring regulatory excellence and public-health protection. Provide leadership, mentoring, and capacity building: recruit or manage a team of scientific advisers/regulators; develop internal competencies; foster a service culture focused on excellence, stakeholder-orientation, and regulatory integrity. Reporting & Accountability Reports to an Executive Director of Healthcare Quality and Access. The agency’s board of directors includes the HQ&A Executive Director. Responsible for leading the Scientific Advice Service team (or establishing such team), defining professional standards, managing resource allocation, and overseeing delivery of advice outputs. Accountable for aligning the service with MHRA’s core goals: safe and timely access to medicines and devices, regulatory quality, innovation facilitation, and public-health protection. Person Specification: Method of assessment: A=Application, T=Test, I=Interview, P=Presentation Behaviour Criteria: Seeing the Big Picture - Strategic vision and systems-thinking: able to shape and drive a Scientific Advice Service aligned with HQ&A and MHRA long-term objectives. (A,I) Communicating and Influencing - Excellent written and verbal communication skills — able to translate complex technical/regulatory information into actionable advice tailored for diverse stakeholders (industry, academic, internal, policy). (P) Working Together - Stakeholder engagement and collaboration — able to build and maintain trust with external stakeholders, collaborate across internal MHRA functions, and contribute to cross-agency initiatives. (A) Leadership - Capable of leading a multidisciplinary team, managing resources and priorities, mentoring staff, and building service capacity. (I) Managing a Quality Service - Enables provision of authoritative, evidence-based regulatory advice on medicines, delivering high-quality, timely guidance with a strong customer-service ethos and a clear focus on stakeholder needs. (P) Experience Criteria: Track record in strategic leadership, service development or organisational change — capable of building a new service and guiding it to maturity in a complex regulatory environment. (A) (Lead criteria) Extensive experience in regulatory science, drug/device development, regulatory affairs, or equivalent — ideally across a range of product types (small molecules, biologics, devices, ATMPs). (A,I) Demonstrable experience in providing a customer driven service — for example in industry, academia, regulators, or other relevant organisations. (I) Technical Criteria: Advanced scientific/biomedical/pharmaceutical degree (e.g. MSc, PhD), or equivalent clinical/technological qualification — ideally covering medicines, biologics, medical devices or advanced therapies. (A) Strong analytical and critical-appraisal skills — to assess complex scientific, clinical, quality and regulatory data, identify risks/benefits, and provide high-quality advice. (A) Strengths Criteria Adaptable — adept at working in a fast-evolving environment, responding to emerging science and regulatory change, and balancing competing demands. (I) 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. Presentation, to be prepared as part of your interview, with further information being supplied when you reach this stage. 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 a track record in strategic leadership, service development or organisational change — capable of building a new service and guiding it to maturity in a complex regulatory environment. 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 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. 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: 10/3/2026 Shortlisting date:18/03/2026 Interview date: 30/03/2026 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. 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. Standard Cabinet Office rules on pay will apply to civil servants appointed on level transfer or promotion. Their salary will increase to the minimum of the SCS PB1 range or by a promotion award of up to 10% more than their current basic salary excluding all allowances (whichever is the greater). Individuals appointed on level transfer will retain their existing basic salary excluding all allowances. You may be eligible for a non-consolidated annual bonus payment, subject to successful performance, in line with the Senior Civil Service pay arrangements. These are set annually within the guidelines laid down by the Cabinet Office. 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 careers@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 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 two main centres and peripatetically across the UK and abroad. The agency consists of Corporate, Digital & Technology, Enablement, Healthcare Quality & Access, Partnerships, Safety & Surveillance and Scientific Research & Innovation.

Responsibilities

This role involves leading the establishment and development of a Scientific Advice Service within the MHRA to provide high-quality scientific and regulatory guidance to external stakeholders supporting UK market access for medicines and medical devices. Key duties include designing the operational model, overseeing advice delivery across domains like quality and clinical development, and ensuring alignment with the agency's mission for quality and safety.