Deputy Director, Scientific Advice

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.

Whats the role

As Deputy Director Scientific Advice this role will lead the establishment and development of a Scientific Advice Service embedded inMHRAprovide 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 MHRAs 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 supportsHQ&As objectives: licensing market access regulatory/quality evaluation accelerated-access pathways and compliance with regulatory standards. (HQ&As 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&As public-health mandate.
• For complex or novel cases (e.g. biologics ATMPs combination products devicedrug interfaces)providesenior-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 whereappropriate 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 agencys regulatory and access workflow.
• Contribute to HQ&A and broader MHRA strategicobjectives: enabling safetimelyaccess 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 toanExecutive Director of Healthcare Quality and Access. The agencys board of directors includes the HQ&A Executive Director.
• Responsible for leading the Scientific Advice Service team (orestablishingsuch team) defining professional standards managing resource allocation and overseeing delivery of advice outputs.
• Accountable for aligning the service with MHRAs core goals: safe andtimelyaccess to medicines and devices regulatory quality innovation facilitation and public-health protection.

Person Specification:

Method of assessment: AApplication TTest IInterview PPresentation

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-termobjectives. (AI)
• 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 andmaintaintrust 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 ofauthoritative evidence-based regulatory advice on medicines delivering high-qualitytimelyguidance with a strong customer-service ethos and a clear focus on stakeholder needs.(P)

Experience Criteria:

• Track record in strategic leadership servicedevelopmentor 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).(AI)
• Demonstrable experience in providinga 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) orequivalent clinical/technological qualification ideally covering medicines biologics medicaldevicesor advanced therapies.(A)
• Strong analytical and critical-appraisal skills to assess complex scientific clinicalqualityand regulatory dataidentifyrisks/benefits andprovidehigh-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!

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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.

• 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 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 atrack record in strategic leadership servicedevelopmentor 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 allowsufficienttime. 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 ourcandidate guidancefor more information on appropriate and inappropriate use.

If you require any disability related adjustments at any point during the process please contact 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 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.

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 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.

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.

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

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