Regulatory Affairs Manager

11 drugs developed. 6 million courses of treatment. Immeasurable lives improved.

Regulatory Affairs Manager

£50,000 - £60,000 plus benefits

Reports to:Senior Regulatory Affairs Manager (Team Lead)

Directorate:Research & Innovation

Contract:Permanent

Hours:Full time 35 hours per week

Location:Stratford, London Office-based with high flexibility (1-2 days per week in the office)or home based with occasional travel to our head office in Stratford, London (4-6 times per year).

Closing date:23 June 2025 23:55

This vacancy may close earlier if a high volume of applications is received or once a suitable candidate is found, therefore we strongly recommend that you apply early to avoid disappointment. Please let us know if there is anything about the recruitment process that you would like to discuss, in particular if there are any changes or adjustments that would make it easier for you to apply. Please contact or as soon as possible.

Visa sponsorship:You must be eligible to work in the UK to apply for this vacancy. Cancer Research UK isnotable to offer visa sponsorship.

Recruitment process:Screening calls followed by Teams Competency Based Interview

Interview date:w/c 14 July 2025

At Cancer Research UK, we exist to beat cancer.

Cancer Research UK are looking for an experienced regulatory affairs professional to join our Centre for Drug Development as a Regulatory Affairs Manager

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. 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.

It is an exciting time for CDD as we're expanding our teams to move forward with an ambitious new strategy to maximise the impact of our research to benefit patients. Several teams are hiring new roles to make this new strategy a reality, expanding the size of our project portfolio and bringing in new skills as we work more internationally.

This is a great opportunity for a regulatory affairs expert, within the area of clinical trials, to gain valuable experience within a broad range of phase 1 oncology trials spanning the UK and Europe.

What will I 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 you looking for?

• Degree in a scientific discipline or equivalent relevant experience.
• Experience of working in regulatory affairs, particularly in the area of clinical trials
• 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 organisation values are designed to guide all that we do.

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.

If you're interested in applying and excited about working with us but are unsure if you have the right skills and experience we'd still love to hear from you.

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.

You can explore our benefits by visiting our careers web page.

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.

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