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    Regulatory Affairs CMC Manager - Leeds, United Kingdom - Proclinical Staffing

    Proclinical Staffing
    Proclinical Staffing Leeds, United Kingdom

    5 days ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Regulatory Affairs CMC Manager - Remote - Contract

    Proclinical is seeking a Regulatory Affairs CMC Manager to support global commercial post-approval submissions. This is a remote contract position.

    Primary Responsibilities:

    This role involves working closely with regulatory CMC and cross-functional teams to ensure the successful execution of commercial filing plans.

    Skills & Requirements:

    • Knowledge of regulations and guidelines governing the development, licensure, and marketing of chemical drugs, biologics, or gene therapies.
    • Strong project management skills.
    • Excellent communication and collaboration skills.
    • Ability to identify issues and develop risk mitigation strategies.

    The Regulatory Affairs CMC Manager will:

    • Represent regulatory CMC at relevant site meetings and provide timely and accurate feedback to support site initiatives.
    • Manage the compilation of all necessary documentation for commercial regulatory CMC submissions and responses to questions, ensuring high quality and compliance with regulations and guidelines.
    • Collaborate with U.S. and UK teams to prepare change controls and GMP documentation to support global submissions for product registrations and/or renewals.
    • Participate in cross-functional project teams as a regulatory CMC representative, ensuring consistent communication within the department and with other functional areas.
    • Proactively identify issues and suggest appropriate strategies to mitigate risks.
    • Assist in the preparation for interactions with global regulatory authorities.

    If you are having difficulty in applying or if you have any questions, please contact Caitlin Siljeur at .

    Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

    Proclinical Staffing is an equal opportunity employer.

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