Head of Medicines Assessment Team (Innovative or Established Medicines Licensing)

The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s sovereign regulator for medicines, including biological medicines, medical devices, and blood products. Our primary purpose is to ensure that products intended for the UK market are safe and effective and to monitor the ongoing safety of licensed products.

We are currently looking for a 2 x Head of Medicine (Innovative or Established Medicines) to join our Healthcare Quality and Access Group.

The objective of the Healthcare Quality and Access group 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 to enable licensing and market access, as well as ensuring compliance with regulations and standards.

The Innovative Medicines function delivers a risk appropriate critical appraisal of quality, safety and efficacy of innovative medicinal products, determining whether a product’s benefits outweighs the risks. It aims to accelerate their route to market to drive earlier patient access. Through this function the Agency will be seen as a leader in facilitating early access to safe and innovative medicines attracting the life sciences sector and contributing to a positive patient experience and to the improvement of public health outcomes.

The Established Medicines function within the Healthcare Quality and Access group delivers a risk appropriate critical appraisal of quality, safety and efficacy of healthcare products that are vital to the NHS and wider population, determining whether a product’s benefits outweigh the risks. This includes our work on established medicines, complementary medicines, self-medication, parallel imports, and unlicensed imports. This enables access whilst ultimately reducing costs to the healthcare system and delivering positive patient benefits as a result.

Role Purpose

The post holder is part of the Innovative Medicines and Established Medicines senior leadership team. The post holder will provide operational management support for one of the medicine assessment teams that evaluate marketing authorisation applications and variation applications for chemical new active substances and established medicines. The post holder’s team will assess applications via national or international recognition routes across one or more therapeutic areas. The post holder will provide guidance and direction to the team to drive a targeted and risk proportionate evaluation of benefits and risks in the context of the UK healthcare system.

In addition to managing a medicines assessment team, the post holder may be asked to manage at least one specialist team which supports the function of Innovative Medicines and Established Medicines. The post holder will support matrix working across the Innovative Medicines, Established Medicines and Authorisation Lifecycle areas of HQA as necessary.

Key Responsibilities

• Provide leadership and management to the medicines assessment team (and potentially specialist teams), including the training and development of individual staff and the team, managing their performance.
• Contribute to the wider management of the Innovative Medicines and Established Medicines function, motivating and developing teams to ensure delivery of targets and objectives focussed on patients and public.
• Ensure the quality of assessment decisions made across the team to protect public health.
• Maintain oversight of all scientific and regulatory issues relating to medicines evaluation ensuring the smooth operation of procedural and business processes associated with authorisation of medicines.
• Manage workload and allocation within the team, working in conjunction with other teams in the Innovative Medicine, Established Medicines and Authorisation Lifecycle areas as needed.
• Contribute to Agency policy, engage with stakeholders and respond to issues and requests that arise.
• Collaborate with other Agency employees and stakeholders to manage projects and implement changes to legislation, information processing and work systems as necessary.

In addition, the post holder will be required to:

• Create a sense of purpose for colleagues through highlighting connections between our work and the impact on patients and the public, inspiring colleagues to be fully engaged in their work.
• Deliver difficult or complex messages with decisiveness, clarity and sensitivity, being persuasive when required.
• Promote diversity, inclusion and equality of opportunity, respecting difference and external experience.
• Ensure team members are accountable: empowered to make decisions, innovate and challenge without being blamed.
• Be self-aware and role-model continuous self-learning and development.

The job description is not intended to be exhaustive, and it is likely that duties may be altered from time to time in the light of changing circumstances and after consultation with the postholder.

Degree in pharmacy, medicine or other relevant science discipline.

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)

This vacancy is using Success Profiles (opens in a new window), and will assess your Behaviours and Experience.

Please provide a 2 page Anonymised CV which sets out your career history, previous experience and skills, highlighting specific responsibilities that are relevant for this role.

We have also included a pre-sift question to complete. Should we receive a high number of applications we will use this as our pre sift criteria. The question must be answered and will appear on the portal as follows; Candidates who do not provide a CV and sufficient answer to the pre sift question will not be invited to interview.

Pre-sift question: In no more than 300 words describe the extent of your experience in regulatory assessments, regulatory affairs or development of medicinal products for marketing authorisation applications and why this experience is relevant to the role.

We are only able to offer feedback at interview stage.

Those invited to interview will receive a presentation topic to be prepared ahead of the day to begin the interview. No more than 5 minutes before questions.

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