Regulatory Affairs Manager in Stratford-upon-Avon

Cancer Research UK are looking for an experienced regulatory affairs professional to join our Centre for Drug Development as a Regulatory Affairs Manager. Experience in chemistry, manufacturing and controls (CMC) would be an advantage, but is not essential.

The Cancer Research UK Centre for Drug Development (CDD) is the world’s only charity-funded drug development facility. Our pioneering research is driven purely by the goal to see scientific breakthroughs bring benefits to patients sooner. CDD is the sponsor of early phase and precision medicine clinical trials in oncology agents. Our broad portfolio rivals that of a medium-sized pharmaceutical company, spanning antibodies, cell therapies, vaccines, drug conjugates and small molecules, making this an interesting and dynamic area to work in.

In this role you’ll be providing expert regulatory advice and support to cross‑functional project teams within the CDD, supporting the preclinical development and clinical trials of a varied portfolio of novel oncology products. Any background in CMC can further support the development of regulatory strategies for our trials. Our regulatory managers are responsible for managing the submission and on‑going maintenance of optimal Clinical Trial Authorisation (CTA) applications both in the UK and EU, ensuring compliance with the current Clinical Trial legislation. This is an excellent opportunity for a regulatory affairs expert to gain valuable experience across a broad range of early‑phase oncology trials spanning the UK and Europe.

What will you be doing?

• Working in cross‑functional project teams, to provide expert regulatory guidance and input to support the project strategy from portfolio entry through to trial completion.
• Advising on CTA documentation requirements, agreeing responsibilities, managing review processes and submission timelines.
• Co‑ordinating and submitting optimal Clinical Trial Authorisation (CTA) applications in compliance with CDD standard operating procedures (SOPs) and current UK and EU regulatory agency requirements.
• Leading internal discussions to respond to questions raised, ensuring responses are submitted within the required timeframe.
• Leading the production of the Investigational Medicinal Product Dossier (IMPD) for designated projects, writing sections and liaising with other team members and third‑party contacts as appropriate.
• Providing general regulatory advice to CDD (and CRUK) and contributing to the continuous review and improvement of systems and processes, to ensure regulatory compliance and best practice.

What are we looking for?

• Degree in a scientific discipline or equivalent relevant experience.
• Experience of working in regulatory affairs, especially around clinical trials, with any additional CMC expertise considered desirable.
• Ability to apply specialist regulatory knowledge and experience to support the regulatory aspects of early phase drug development in the Charity.
• Experience of writing and reviewing IMPDs and other regulatory documents, including ability to interpret and accurately summarise complex scientific data for inclusion in regulatory packages.
• Able to work independently with minimal supervision, proactively managing own workload and assuming regulatory lead role on designated projects with accountability for regulatory output and associated project deliverables.
• Excellent knowledge of current Clinical Trial Legislation, specifically UK and EU and particularly in relation to first‑in‑human trials.
• Skilled in assessing and effectively communicating information within project teams and to senior managers.

Our values:

• Bold: Act with ambition, courage and determination
• Credible: Act with rigour and professionalism
• Human: Act to have a positive impact on people
• Together: Act inclusively and collaboratively

We’re looking for people who can believe in and embody these organisation values and can use them to drive forward progress against our mission to beat cancer.

What will I gain?

We create a working environment that supports your wellbeing and provide a generous benefits package, a wide range of career and personal development opportunities and high‑quality tools. Our policies and processes enable you to improve your work‑life balance, take positive steps in your career and achieve your personal wellbeing goals.

How do I apply?

We operate an anonymised shortlisting process in our commitment to equality, diversity and inclusion. CVs are required for all applications; but we won’t be able to view them until we invite you for an interview. Instead, we ask you to complete the work history section of the online application form for us to be able to assess you fairly and objectively.

For more information on this career opportunity please visit our website or contact us at recruitment@cancer.org.uk.

Our vision is to create a charity where everyone feels like they belong, benefits from and participates in, the work we do. We actively encourage applications from people of all backgrounds and cultures, in particular those from ethnic minority backgrounds who are currently under‑represented.

Please contact recruitment@cancer.org.uk or 020 3469 8400 as soon as possible if you have any concerns or adjustments you might need to enable this to happen.