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

    Park Street People
    Park Street People Uxbridge, United Kingdom

    1 week ago

    Default job background
    Healthcare
    Description

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

    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
    Oversee all regulatory submissions as well as reviewing and altering dossiers as necessary ensuring that these are compliant
    Liaise with and build good relationships with affiliates, sites, regulatory agencies and other internal and external stakeholders
    Maintain an active awareness of EU and EEMEa Regulatory legislationRequirements
    Previous experience in UK EU regional Regulatory Affairs and Compliance particularly within the pharmaceutical industry
    Full regulatory lifecycle process experience highly advantageous
    Good understanding of regulatory procedures such as CTAS, marketing authorisations and post approval
    Strong communication and stakeholder engagement skills
    Proactive mannerPark 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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