PRAHS

  • Regulatory Affairs Associate (RAA)

    Job Locations - | UA-Kiev
    Posted Date 3 weeks ago(7/26/2018 8:16 AM)
    ID
    2018-47911
  • Overview

    PRA Health Sciences are a Clinical Research Organisation committed to developing our people.

     

    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

    This role offers the right candidate the opportunity to join a fast growing and developing Global Regulatory Affairs team. The Local Regulatory Affairs Associate (LRAA) manages the activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), Central Independent Ethics Committee (IEC) and any other central authorities for the assigned country/countries.

     

    Summary of accountabilities:

    • Liaison with competent authorities
    • Management of preparation, review and coordination of Regulatory submissions on a country level
    • Act as a key contact on a country level for all submission related activities and provide oversight for projects
    • Management of the country adaptation of the  Informed Consent Forms and any other patients’ documentation.
    • Tracking and reporting of projects progress in Clinical Trials Management System (CTMS), eTMF and other applicable Company systems
    • Perform the role of Local Reviewer in the QC process of the submissions as appropriate.
    • Providing consultancy to the client on any country regulatory specifics if requested.

    Qualifications

    You are:

     

    A quality focused self-starter with ambition to learn and develop.

     

    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:

    • An undergraduate degree ideally in science, or health-related field.
    • Good knowledge of applicable ICH Guidelines and applicable regional /national regulatory requirements.
    • Relevant regulatory experience with any types of submissions is a plus
    • The ability to understand new guidelines and regulations as they are issued by major regulatory authorities in the region
    • Strong communication skills and fluency in written and spoken Ukrainian and English
    • Ability to work as a team player, focusing on solving projects issues in team-oriented environment.

     

    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.

     

    PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.

     

    For more information please visit our website: www.prahs.com

     

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