PRAHS

  • Regulatory Labelling Manager

    Job Locations (All) | United Kingdom-London | Netherlands | Germany | France | Belgium | Spain | Italy
    Posted Date 3 weeks ago(10/26/2018 10:26 AM)
    ID
    2018-50008
  • Overview

    We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA.

    Responsibilities

    Position overview:

     

    Following recent expansion of our client portfolio, we are seeking to hire an experienced Regulatory Labelling Manager, to work dedicated to one of our key biotech clients. This role sits within our EU Labelling operations function.

     

    Working under the strategic guidance of the EU Regulatory Strategist and reporting to the EU Labelling Operations Senior Manager, the overall aim of the Regulatory Labelling Manager will be to provide regulatory labelling expertise to regulatory teams and stakeholders on the development and submission of European labelling documents for EU health authority review.

     

    Leveraging your subject matter expertise and knowledge of EU labelling requirements, your main tasks will include:

     

    • Coordinating pre and post approval labelling activities
    • Creating and maintaining a project calendar, collaborating with the Regulatory Strategy Lead for project updates and timelines
    • Providing subject-matter expertise on EU regulatory labelling requirements to the wider regulatory team, responding to queries from the regulatory strategy team at client-side
    • Working with colleagues client-side for artwork creation and revision, coordinating artwork implementation and QC
    • Managing and tracking job routing to receive comments and obtain approvals
    • Performing quality checks and content audits of labelling documents to ensure adherence to EU regulatory requirements and formatting guidelines
    • Initiating workflows in the document management system
    • Working with and managing vendors for translation services (where applicable) or local affiliates

     

    This role represents a key growth step in our labelling function. As such, you will be at the forefront of our evolution as a labelling team, and you can expect your career to grow in line with this expansion and to carve out a niche for yourself in this growing department.

    Qualifications

    You are:

     

    Adaptable, dedicated and collaborative.

    Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

    • A proven track record within EU labelling including pre and post approval activities, artwork creation and revision, creation and review of labelling updates and working with translation vendors and local affiliates
    • An expert understanding of EU regulatory requirements
    • A relevant degree-level qualification in a life-sciences discipline
    • A demonstrable ability to collaborate with others in a global time-critical environment, along with a commitment to delivering high-quality work

     

    Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.

     

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