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Head of Regulatory

Quality & Laboratory
Cork
Therese Keohane
Permanent
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Job Reference: JO-1911-64864_1574165189

Summary:


Job Purpose



  • Technical expertise on Chemistry, Manufacturing & Controls and clinical issues within the local affiliate

  • Support the cluster regulatory functions with CMC knowledge and regulatory expertise

  • Lead on regulatory, financial and technical compliance within Ireland

  • Support the Managing Director, Ireland as part of the senior leadership team in Ireland



Job Summary



  • Regulatory expert for Ireland

  • Knowledge of HPRA and European regulatory systems

  • Creation of regulatory documentation

  • Regulatory due diligence activities on behalf of Portfolio

  • Ensuring there is financial oversight of the Regulatory budget in Ireland to ensure adherence to financial compliance requirements

  • Development and management of CAPA and performance metrics associated with regulatory function

  • Training internal and external

  • Be part of the Irish Senior Leadership Team



Requirements



  • Graduate in a scientific discipline (life sciences, chemistry or pharmacy)

  • Experience of working in a fast paced constantly changing environment

  • Ability to work as part of a multifunctional team

  • Regulatory knowledge and expertise

  • Good understanding of relevant IE/EU legislation

  • Experience of working within a global matrix organisation

  • Excellent communication and interpersonal skills

  • Proactive approach to problem solving

  • Good time management skills

  • Flexibility in line with changing priorities

  • Meticulous attention to detail

  • Experience of software packages such as Word, Excel and Outlook




Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.


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Therese Keohane
Therese Keohane
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Quality & Laboratory
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