PRAHS

  • Regulatory Affairs Associate

    Job Locations - | Thailand
    Posted Date 4 days ago(7/12/2018 9:53 PM)
    ID
    2018-47912
  • Overview

    Regulatory Affairs Associate

    Location: Thailand

     

    Providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive to move drug discovery forward, to help them develop lifesaving and life-improving drugs. We help change people’s lives for the better every single day. It’s who we are. And it’s who you could be too. 

    Responsibilities

    •  The tasks undertaken by a RAA are varied and can include:

      • Management of 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.
      • Management of central/country level submissions associated with ensuring Investigational Product (IP) and any other clinical trial supplies can be imported and where applicable, exported into/from the country(s) the LRAA is responsible for.
      • Ensuring that IP labels are in adherence to country requirements and submitted where applicable.
      • Management of the central/country level Informed Consent and any other documentation given to patients i.e. diaries, questionnaires 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 by the Start-Up Lead (SUL), GRAL, Clinical Team Manager (CTM) or Project Manager (PM).
      • Supporting the Senior level Regulatory staff/Country Consultant in the maintenance of the accurate, up to date Country Knowledge Repository.
      • Attending internal and external project team meetings as determined by the GRAL, SUL, CTM or PM.
      • If applicable for the Country, submit expeditable safety reports to RAs and central IECs in accordance with relevant legislation and the project-specific contractual agreement.
      • Any other duties deemed necessary to secure the success of PRA’s business.
      • Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and BDMs.
      • Contribute to the maintenance and collection of Regulatory Intelligence by ensuring that tools such as the Country Knowledge Repository and the Country Fact Sheets are up to date; communicate new information or changes to the Regulatory Intelligence Consultant team.  
      • May work with GRA team members to provide Regulatory consulting services
      • Provide mentoring and training for the RAA 1 position.
      • Support RAA 1 with more complex submissions.
      • May serve as Country Consultant.
      • May liaise with team/other department members to validate Country Intelligence before liaising with the appropriate GRA team member to ensure that the information is disseminated appropriately.

    Qualifications

    • Detail-orientated, passionate and reliable.

       

      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:

       

        • Strong knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations as they relate to pharmaceutical, biological, biosimilar, and medical device product development.
        • Minimum 2 year prior experience preparing RA and Central IEC submissions for Clinical Trial Applications preferred.
        • Strong knowledge of current regional guidelines and regulations is preferred, as well as the ability to understand new guidelines and regulations as they are issued by major regulatory authorities in the region.
        • Prior experience using computerized information systems required; experience with PC Windows, word processing, and electronic spreadsheets required.
        • Read, write, and speak fluent English; fluent in host country language.
        • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution or a licensed healthcare professional (i.e. registered nurse) required

       

      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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