Regulatory Affairs Associate

Cancer Research UK (CRUK)

Regulatory Affairs Associate supporting clinical trial authorisation and compliance at Cancer Research UK. Prepare and submit regulatory documents while collaborating with multidisciplinary teams in drug development.

Posted 5/2/2026full-timeStratford • 🇬🇧 United KingdomMid-LevelSenior💰 £38,000 - £43,500 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Work with the Regulatory Affairs Manager (RAM)/Senior RAM (Team Lead) in the preparation and submission of initial clinical trial authorisation (CTA) and subsequent modifications/notifications to the UK and EU regulatory agencies as required for each of the designated projects.
Act as internal regulatory representative on designated projects with support from RAM/Senior RAM (Team Lead), attending project and study team meetings and providing general regulatory guidance to project/study teams.
Lead discussion around regulatory strategy for designated projects, agreeing documentation requirements for initial applications, classification of modifications and document updates required with support from RAM/Senior RAM (Team Lead).
Lead the production and review of Investigational Medicinal Product Dossiers (IMPD) for designated projects with support from RAM/Senior RAM (Team Lead), writing sections, liaising with other members of the Internal Project Team, external manufacturing organisations and third-party contacts as appropriate to finalise the document.
Prepare/review additional CTA documents as required for designated projects and as requested by the RAM/Senior RAM (Team Lead).
Prepare modifications and notifications for designated projects and as requested by the RAM/Senior RAM (Team Lead).

Requirements

What you’ll need

BSc. (Hons) qualification in a scientific discipline (or equivalent level of experience)
Highly computer literate (extensive experience of standard Microsoft packages)
Previous experience in the pharmaceutical industry (or equivalent), ideally in a regulatory capacity
Familiarity with ICH/GCP guidelines, the UK and EU Clinical Trials legislation
Good understanding of the drug development process and clinical trials
Experience of preparing and reviewing regulatory documents for submission to UK and EU regulators - desirable
Experience of first in human and/or early phase oncology trials - desirable.

Benefits

Comp & perks

flexible working requests considered
generous benefits package
wide range of career and personal development opportunities
high-quality tools

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial authorisationInvestigational Medicinal Product Dossierregulatory document preparationregulatory strategy developmentmodification documentationdrug development processclinical trialsfirst in human trialsearly phase oncology trialsICH/GCP guidelines

Soft Skills

regulatory guidancecommunicationteam collaborationleadership

Certifications

BSc. (Hons) in a scientific discipline