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Slough

    Quality Consultant - Slough, Berkshire, United Kingdom - Cpl Life Sciences

    Default job background
    £65 - £75
    Description

    Job Title:
    Regulatory Affairs CTA, CTR Manager/Consultant (Inside IR35)

    Job Type: 12-month contract
    Berkshire, UK – Hybrid

    Pay Rate:
    £65-75 per hour (PAYE)

    We are partnered with a leading Pharmaceutical organization who are looking for an experienced Regulatory Consultant to join on a 12-month contract basis.

    You will work as a Regulatory EU CTR SME and support several EU CTR submissions.

    As a Regulatory Affairs Professional, you will assume a crucial role in providing leadership and expertise in all regulatory and submission-related aspects of clinical trials.

    Additionally, you will actively participate in EU-CTR consulting and contribute to the operational implementation aspects of the EU-CTR directive, ensuring effective collaboration between departments.

    Lead/support all CTR initial submissions, transitions, amendments, and re-submissions
    Participate in EU-CTR consulting and contributing to its operational implementation
    Provide leadership and expertise in regulatory and submissions-related aspects of clinical trials
    Offer guidance on submissions expertise to junior team members
    A degree in a scientific discipline
    Experience in Regulatory Affairs
    Good level of knowledge of Clinical Trial Submissions on a local and regional level
    Fluent in English is a must (written and spoken)


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