Jobs

    CMC Regulatory Affairs Associate - Uxbridge, United Kingdom - Park Street People

    Park Street People
    Park Street People Uxbridge, United Kingdom

    1 week ago

    Default job background
    Temporary, Full time
    Description

    Our client, a global pharmaceutical company, is currently looking for a CMC Regulatory Affairs Associate to join their team in Uxbridge.

    Working in a busy global department, there is a focus on working together to achieve results. You would be joining a company with an exciting pipeline who are continually developing their drug portfolio.


    This is a great opportunity to work for a pharmaceutical company who have created a centre of excellence and constantly focus on driving innovation and using cutting edge techniques in their science.

    Key Responsibilities

    A key role in the execution of CMC regulatory strategies working on multiple cross functional projects
    Putting together and altering dossiers as well as electronic dossier/document management
    Working on CMC submissions
    Liaise with and build good relationships with affiliates, sites, regulatory agencies and other internal and external stakeholders
    Maintain an active awareness of EU and EMEA Regulatory legislationRequirements

    Previous experience in UK/EU regulatory affairs or a background in quality control/assurance
    CMC experience, specifically working on CMC submissions for clinical trials and marketing applications
    Exposure to Regulatory Affairs legislation and procedures
    Degree educated or demonstrable knowledge in biochemistry or chemistry highly advantageous
    Strong communication and interpersonal skillsPark Street People Ltd is an Equal Opportunities Employer.

    We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation.

    We are acting as an Employment Business in relation to this role
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