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: 09 March 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.
Visa sponsorship: You must be eligible to work in the UK to apply for this vacancy. Cancer Research UK is not able to offer visa sponsorship.
Recruitment process: Screening calls followed by Teams Competency Based Interview
Interview date: w/c 24 March 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.
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.
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 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.
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. #J-18808-Ljbffr