Regulatory Affairs Manager – Oncology Trials (UK/EU CTA)

Cancer Research UK
Edinburgh
3 days ago
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11 drugs developed. 6 million courses of treatment. Immeasurable lives improved.

Regulatory Affairs Manager

£55,000- £60,000plusbenefits

Reports to:SeniorRegulatory AffairsManager (Team Lead)
Directorate: Research & Innovation
Contract: 12 months, Fixed Term Contract
Hours: Full time 35 hours per week
Location: Stratford, London Office-based with high flexibility (1-2 days per week in the office) . We’re happy to offer home-based contracts through our flexible working policy. While this role does involve occasional travel to the office typically 4 to 6 times a year, please note that travel expenses to and from the office are not covered. We aim to keep travel minimal and purposeful, ensuring it adds real value to your work and team collaboration.
Closing date:1stApril 202623:55pm
Recruitment process:Screening calls followed by TeamsCompetency Based Interview
Interview date:w/c20thApril 2026

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

At Cancer Research UK, we exist to beat cancer.

Cancer Research UK are looking for an experiencedregulatory affairs professional tojoin our Centre for Drug Developmentas 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, drugconjugatesand small molecules, making this an interesting and dynamic area to work in.

In this roleyou’llbe providingexpert regulatory advice and support to cross-functional project teamswithin the CDD, supporting the preclinical developmentand clinical trials of a varied portfolio of novel oncology products. Any background in CMC can further support the development ofregulatory strategiesfor our trials.

Our regulatory managersare responsible formanaging the submission and on-going maintenance ofoptimalClinical Trial Authorisation (CTA) applicationsboth in the UK and EU, ensuring compliance with the current Clinical Trial legislation.

This is anexcellentopportunityfor a regulatory affairsexpert to gain valuable experience acrossa broad range ofearly-phase oncology trials spanning the UK and Europe.Experience in CMC, particularly within early phase clinical trials would be advantageous.It is an exciting time for CDD as our teamsare working to deliveran ambitious new strategy to maximise the impact of our research tobenefitpatients - Ourproject portfoliohas recently expanded in sizeaswemove forward with trials both in the UK andEU.

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 andsubmittingoptimalClinical Trial Authorisation (CTA) applications in compliance with CDD standard operating procedures (SOPs) and currentUK and EUregulatory agency requirements. Leading internal discussions to respond to questions raised, ensuring responses aresubmittedwithin the requiredtimeframe.

  • Leading the production of the Investigational Medicinal Product Dossier (IMPD) for designated projects, writingsectionsand liaising with other team members andthird-partycontacts asappropriate.

  • Providinggeneral 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.

Whatarewelooking for?

  • Degree in a scientific discipline or equivalent relevant experience.

  • Experience of working in regulatory affairs, especiallyaroundclinical trials, with any additional CMC expertise considered desirable.

  • Ability to apply specialist regulatory knowledge and experience to support the regulatory aspects ofearly phasedrug 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 EUand 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,courageand determination

Credible: Act with rigour and professionalism

Human: Act to have a positive impact on people

Together: Act inclusively and collaboratively

We’relooking 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.

Ifyou’reinterested in applying and excited about working with us but are unsure if you have the right skills andexperiencewe’dstill love to hear from you.

What will I gain?

Wecreate a working environment that supports your wellbeing andprovide agenerous benefits package, a wide range of career and personal development opportunities and high-quality tools. Ourpolicies and processes enable you toimprove your work-life balance, take positive steps in your career and achieve your personal wellbeing goals.

You can explore our benefitsby visitingourcareers web page.

How do I apply?

Weoperatean anonymised shortlisting process in our commitment to equality,diversityand inclusion. CVs arerequiredfor all applications; but wewon’tbe 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 pleasevisit our websiteor contact us at.

For more updates on our work and careers, follow us on:Linked In,Facebook,Instagram,XandYouTube.

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.

We want to see every candidate performing at their best throughout the job application process, interview process and whilst at work. We therefore ask you to inform us of any concerns you have or any adjustments you might need to enable this to happen. Please contact or 0 20 3469 8400 as soon as possible.

Unfortunately, we are unable to recruit anyone below the age of 18, so that we can protect young people from health & safety and safeguarding risks.


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