Regulatory Affairs Manager

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Job description

*Do not delay applying as we are shortlisting on application and may close earlier should a suitable candidate be found.*

*Application:* CV and cover letter explaining how your skills and experience are relevant for the role.

More detailed information about the role and Cancer Research UK can be found in the [Candidate Pack](:aaid:scds:US:b51a9676-7d29-4311-b53e-d184b1c4c164)

*Are you passionate about drug development and being in an organisation focused on bringing the forward the day when all cancers are cured?*

This exciting new role sits within the CRUK Centre for Drug Development (CDD), our goal is to bring much needed new treatments to people with cancer. We would welcome applications from those with a drug development background looking to utilise their scientific expertise in varied regulatory focused 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, 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 CTA applications in compliance with CDD standard operating procedures and current 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 skills do I need?*

* Degree in a scientific discipline or equivalent relevant experience.

* Ability to apply specialist regulatory knowledge and experience to support the regulatory aspects of 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.

* Knowledge of current Clinical Trial Legislation, specifically UK.

* Skilled in assessing and effectively communicating information within project teams and to senior managers.

*What will I gain?*

* Opportunity to work on cutting edge early stage drug development and a varied oncology portfolio

* You'll be making a real difference to people's lives - we're the world's largest independent cancer research charity.

* 25 days annual leave plus bank holidays (and the ability to buy up to 5 days per annum) and 1 CRUK day.

* Pension, life assurance and a great benefit discount platform.

If you're as ambitious as we are, join our collective force to help accelerate progress and beat cancer sooner.

At CRUK we value diversity and we're committed to creating an inclusive culture where everyone is able to be themselves and to reach their full potential. We actively encourage applications from people of all backgrounds and cultures and believe that a diverse workforce will help us to beat cancer sooner. 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. Should you need any adjustments to the recruitment process, at either application or interview, please contact us on [](mailto:).