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    Lead Regulatory Associate - Montpellier, France - Pivotal

    Pivotal
    Pivotal Montpellier, France

    il y a 2 semaines

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    Description

    DESCRIPTION:

    We have an open position for a LEAD REGULATORY ASSOCIATE to join our Regulatory Unit within the clinical operations department.

    A Lead Regulatory Associate (LRA) is the contact person for the Sponsor for all regulatory advice and support for the assigned projects. The LRA is responsible for coordinating a team of Regulatory Associates (RAs) in a specific project, for all those tasks related to Regulatory Agencies, Ethics Committees and any other body to obtain the approvals required to perform the study on the participating countries. The LRA also overviews and coordinates the negotiation process of the site contracts/budgets on each country providing updates to the Sponsor.

    • LRA could act as Senior RA on certain countries if required.
    • Hybrid position

    REQUIRED PROFILE: We are looking for candidates with the following skills:

    Science Degree with at least 5 years of experience in Regulatory/start-up in clinical trials. Plus, if you have experience in Regulatory Submission under EUCTR and in UK.

    Sound knowledge of GCPs/ICH and international/local regulations.

    Updated knowledge of national/international regulations relative to clinical Trial Start Up Procedures.

    Previous experience in/with:

    • Preparation of the request for clinical trials authorization
    • Competent Authority (CA) and EC/REC/HRA and R&D submissions
    • Contract and budget negotiation with sites as needed.

    -Fluent in English

    -Team Management

    -Good knowledge of Office (Word, Excel and PowerPoint)

    Above all, we appreciate motivation, excellent team player, and independent and well-structured way of working.

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