Regulatory Affairs Manager
Cancer Research UK (CRUK)
full-time
Posted on:
Location Type: Hybrid
Location: Stratford • United Kingdom
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Salary
💰 £55,000 - £60,000 per year
About the role
- provide expert regulatory advice and support to cross-functional project teams
- supporting the preclinical development and clinical trials of a varied portfolio of novel oncology products
- managing the submission and on-going maintenance of optimal Clinical Trial Authorisation (CTA) applications
- leading internal discussions to respond to questions raised
- producing the Investigational Medicinal Product Dossier (IMPD) for designated projects
Requirements
- Degree in a scientific discipline or equivalent relevant experience
- Experience of working in regulatory affairs, especially around clinical trials
- any additional CMC expertise considered desirable
- Experience of writing and reviewing IMPDs and other regulatory documents
- excellent knowledge of current Clinical Trial Legislation, specifically UK and EU
- ability to apply specialist regulatory knowledge and experience to support the regulatory aspects of early phase drug development
- able to work independently with minimal supervision
- skilled in assessing and effectively communicating information within project teams and to senior managers
Benefits
- generous benefits package
- wide range of career and personal development opportunities
- high-quality tools
- support for wellbeing
- flexible working environment
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory affairsclinical trialsClinical Trial Authorisation (CTA)Investigational Medicinal Product Dossier (IMPD)writing regulatory documentsreviewing regulatory documentsCMC expertiseearly phase drug developmentcurrent Clinical Trial LegislationUK and EU regulations
Soft Skills
expert regulatory advicecross-functional collaborationindependent workcommunication skillsleadershipproblem-solvingproject managementattention to detailability to work with minimal supervisioninterpersonal skills
Certifications
degree in scientific discipline