• Regulatory Affairs Associate

    Job Locations - | Slovakia-Bratislava
    Posted Date 1 week ago(8/9/2018 11:21 AM)
  • Overview

    At PRA, we believe that our people are the future of the industry and therefore we places emphasis on balance. Being able to provide excellence in everything we do comes from recognising that work is a big part of our lives, but it isn’t everything. PRA creates balance by offering flexible work environments and encouraging our workforce to spend time on the important things.


    Position overview:


    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.

    This is a part-time role with the minimum base salary of EUR 24,000/annually (full-time equivalent) and additional benefits.*


    Summary of tasks:

    • Management of country level submissions associated with ensuring Investigational Product and any other clinical trial supplies can be imported / exported into/from the country the LRAA is responsible for.
    • Ensuring that IP labels are in adherence to country requirements and submitted where applicable.
    • Management of the country level Informed Consent and any other documentation given to patients through to submission and approval by country level RA and Central IEC as appropriate.
    • Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable PRA systems.
    • Perform role of Local Reviewer in the QC process as appropriate.
    • Providing consultancy to the client on any country specifics issues if requested.


    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.
    • Knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations as they relate to pharmaceutical, biological, biosimilar, and medical device product development.
    • 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 Slovak and English.


    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.


    *This is the minimum salary offered for the role, however depending on experience, skills and capabilities the compensation will be re-evaluated.


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