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  • Regulatory Affairs Director

    Regulatory Affairs Director, Dublin pharma Our client is a young exciting ambitious biopharmaceutical company with an exceptional newly-created opportunity for a bright capable Regulatory Affairs Manager Position: The Director of Regulatory Affairs is responsible for leading both the strategic and operational aspects of Regulatory Affairs objectives for assigned commercial products, life cycle management initiatives and acquisitions including global regulatory strategy, regulatory submissions, and interaction with regulatory authorities. Responsibilities: Provides regulatory leadership to cross-functional teams, ensuring cross-functional perspective/expertise is incorporated in ...

    Job Type:
    Permanent
    Location:
    Dublin
    Salary:
    N/A
    Job Ref:
    N/A
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  • Associate Director, Director, Global Manufacturing and supply chain

    Associate Director / Director, Global Manufacturing and Supply Chain Job Description Based with a young Dublin pharma start-up, the newly created role of Associate Director/Director, Global Manufacturing & Supply Chain, is responsible for managing the technology transfer, manufacture and supply chain for a commercial injectable product. This includes being the primary point of contact for commercial supply to regional partners. This role is also responsible for managing the supply of appropriately labelled clinical trial materials for study sites in Europe. Other key responsibilities include technology transfer, cross-functional technical audits and vendor management of contract...

    Job Type:
    Permanent
    Location:
    Dublin
    Salary:
    N/A
    Job Ref:
    N/A
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  • Supply Chain Director, Supplier Relationship Management

    Supply Chain Director, Supplier Relationship Management Our client is a highly ambitious fast growing biopharmaceutical company with global headquarters in Dublin. The company’s Supply Chain organisation is tasked with managing the uninterrupted supply of commercial product, including drug substance, drug product and finished goods in various administration technologies through an ever increasing global network of third party Contract Manufacturing Organisations (CMOs). Reporting to the VP of Supply Chain, the Director, Supplier Relationship Management, will support the growth of the business through the management of assigned third party supplier partnerships. Job Spec Operatin...

    Job Type:
    Permanent
    Location:
    Dublin
    Salary:
    100,000 +
    Job Ref:
    N/A
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  • Regulatory Affairs Associate Director / CMC Manager

    Regulatory Affairs Associate Director / Manager CMC, - Dublin Pharma The Associate Director / Manager, Regulatory Affairs Global CMC will be responsible for managing registration and CMC regulatory support for commercial and development projects worldwide. Job Spec : Activities including planning, writing and reviewing Module 2 and 3 CTD sections of all regulatory submissions (INDs, IMPDs, CTAs, MAAs, NDAs, BLAs, meeting requests, and briefing documents). Manage the internal review and submission of these items. Participate and support as an active member of a multi-disciplinary team to establish development and Regulatory CMC strategies for commercial products, late, and early ...

    Job Type:
    Permanent
    Location:
    Dublin
    Salary:
    N/A
    Job Ref:
    122844
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  • Site Lead Biologics

    Site Lead Biologics Our client is a highly profitable fast growing multinational biologics manufacturer based in the greater Dublin area. The company seek to make an executive appointment to head up operationalising biologics operations within this site. The newly appointed Site Lead will be responsible for all site operations in support of commercial drug substance manufacturing. The Site Lead will have overall responsibility for delivery supply to customers according to agreed S&OP supply plans and KPIs. Site activities are inclusive of: plant technical support, manufacturing systems, engineering support, validation execution, technical transfer receiving, manufacturing operat...

    Job Type:
    Permanent
    Location:
    Dublin
    Salary:
    N/A
    Job Ref:
    122823
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