Deputy Director, Scientific Advice

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.

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.

• 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 (re 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.

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!

Contact:

• 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.

Closing date: 10/3/2026

Shortlisting date: 18/03/2026

Interview date: 30/03/2026

If you require any disability related adjustments at any point during the process, please contact as soon as possible.