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  • Regulatory Affairs Lead

    Regulatory Affairs Lead Our client seeks a Regulatory Affairs Lead, who will lead European regulatory affairs, quality systems and compliance for a broad range of Clinical and Commercial medicinal products with EMA, EU and non-EU regulatory bodies. Flexibility exists for this hire, with occasional travel to Dublin site as required. This role will appeal to a Regulatory Affairs Leader who seeks technical challenge of working on cutting edge technology, including gene therapy products, taking drug product candidate through regulatory process from concept right through development to product commercialisation. This position requires substantial experience of gaining MAA and CT appr...

    Job Type:
    Permanent
    Location:
    Ireland
    Salary:
    N/A
    Job Ref:
    124107
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  • Senior Design Assurance Manager, Global role

    Senior Design Assurance Manager, Global role Our client, a Medtech company with strong development and commercial pipeline, now seek an experienced Senior Design Assurance Manager who will work within a global Design Assurance function having responsibility for leading commercial product performance, sustaining engineering and post marketing surveillance activities for a high-value, high-growth therapy area which is supported by significant corporate investment. Flexibility for this hire to work in a hybrid work model, on site in Galway some days as required and from home remainder of time. The successful candidate will provide leadership, oversight and direction to the Sustaini...

    Job Type:
    Permanent
    Location:
    Galway
    Salary:
    N/A
    Job Ref:
    124090
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  • Director Clinical Development (M.D.), Global role

    Director Clinical Development (M.D.), Global role Our client, a cutting edge scientifically driven Biotech company with strong development pipeline and multiple blockbuster products, now seek a unique appointment for a newly created role of Director of Clinical Development based in Ireland, with hybrid working model. This is a Global role, will build Clinical Development function and manage multiple Global Clinical Programs. The ideal candidate will be an experienced Biopharma/ Pharma M.D., who is experienced in working across multiple organizational levels, including leadership teams, executives and steering committees, leading global program direction and status to varying tea...

    Job Type:
    Permanent
    Location:
    Ireland
    Salary:
    N/A
    Job Ref:
    124068
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  • Senior Clinical Project Manager, Global role

    Senior Clinical Project Manager, Global role Our client, a commercial stage Biopharma company with strong development pipeline, now seeks an experienced Clinical Project Manager to work within their Clinical Operations team based in Dublin. This hire will provide oversight and vendor management for the successful management of all aspects of global clinical trials within designated program budgets and timelines. The successful candidate will participate in devising strategy for qualification and selection of CROs for clinical studies. Furthermore, this hire will develop relationships with CROs to ensure that patient enrolment and data collection are completed in accordance with ...

    Job Type:
    Permanent
    Location:
    Dublin
    Salary:
    N/A
    Job Ref:
    124045
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  • Head of Quality GMP, Cell Therapy

    Head of Quality GMP, Cell Therapy Our client, an innovative cell therapy company dedicated to the development of CAR cell therapies, now seek to hire a Head of Quality GMP who will lead the development, implementation and oversight of the company’s quality systems and ensure an appropriate level of effectiveness and compliance with GMP and other relevant regulations. This hire must have equivalent Quality Management/Leadership experience in Cell Therapy drug development. The successful candidate will develop, implement, maintain, and communicate the quality strategy, quality annual plan and quality programs throughout the company, while working closely with the COO and senior le...

    Job Type:
    Permanent
    Location:
    Nationwide
    Salary:
    N/A
    Job Ref:
    124039
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