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Manager, Regulatory Submissions Management - Oferta z Jobs.pl

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Manager, Regulatory Submissions Management

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  • Our client, a pharmaceutical company based in Dublin are now actively recruiting for a Manager, Regulatory Submissions Management. This is a senior post within the organisation. It is permanent and based in Dublin.

    The primary focus of this role is to lead & develop the direct reports within the section and ensure that the department objectives are met and implemented according to agreed management KPIs. The Manager of Submission Management Dublin drives performance excellence and deliverables in the Section to ensure Regulatory compliance within area of responsibility.

    Key Aspects of the Role Include:

    Ensure delivery to Asset targets
    Follow up on team objectives to ensure they are met and strategies are implemente
    Responsible for giving input to the Regulatory Operations budget in collaboration with Head of Submission Management
    Communicate decisions and initiatives within the team and in cooperation with stakeholders
    Ensuring deployment of company strategies and targets/KPIs
    Ensure Submission Execution and Lifecycle Management is in compliance with current regulations and business needs internally and with Sourcing Partne
    People managing the direct reports
    Building project management and knowledge sharing capabilities in the Submission Management department
    Enhancing regulatory and product lifecycle understanding and ways to transfer it into regulatory activities in the department
    Securing the necessary training and development of employees
    Provide employees with the needed support to drive performance

    Experience & Qualifications

    B.Sc. or equivalent third level qualification
    Minimum of 5 years' experience in the pharmaceutical industry.
    Training within management and leadership (e.g. courses or diploma degree).
    2+ years' experience within management - resource management, capacity management, target management, performance management, competency development, motivation of employees, situational management etc.
    3+ years of experience working within different areas of Regulatory Affairs
    Overall knowledge of Pharma and interfacing functions
    Good understanding of key regulatory business processes, & ability to implement and support these
    Good communicator and collaborator

    For more information and to apply for this role please call Linda on 1 or e-mail

    Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: 1


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