PRAHS

  • Regulatory Affairs Associate 1

    Job Locations - | Mexico
    Posted Date 2 weeks ago(2 weeks ago)
    ID
    2018-49151
  • Overview

    The Regulatory Affairs Associate (RAA) fulfills the role of Local Regulatory Affairs Lead (LRAL) and is responsible for preparing, submitting and following up on initial and amended Regulatory Agency (RA), Central Independent Ethics Committee (IEC), and any other central submissions required in the country(s) they are responsible for, within contracted timelines and budget, in accordance with local regulatory requirements and sound scientific/technical principles, including the creation and modification of documentation required for approval. The RAA is responsible for the provision of information relating to local importation and exportation requirements. Where locally appropriate they may be responsible to carry out all practical steps to ensure that importation and exportation requirements  are met for Investigational Product (IP) and any other clinical trial supplies needed for the trial within their country. The RAA is also responsible for providing review of the translation into the local language of clinical trial supply labeling to ensure it meets local regulatory requirements.  Additionally the RAA will ensure that Insurance Certificates, Country Specific Informed Consent forms and any other patient documentation adheres to country requirements.

    Responsibilities

    • Applies knowledge of PRA policies, procedures and office environment
    • Applies knowledge of computerized information systems and standard application software (Windows, MS Office)
    • Demonstrates limited knowledge of clinical research industry practices and standards.
    • Exhibits good communication and interpersonal skills.
    • Demonstrates an ability to understand country specific requirements and how they need to be applied to a clinical trial.

    Qualifications

    • Undergraduate degree or its international equivalent preferably in clinical, science, or health-related field from an accredited institution or a licensed healthcare professional (i.e. registered nurse) required
    • Knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations as they relate to pharmaceutical, biological, biosimilar, and medical device product development.
      Some experience preparing RA and Central IEC submissions for Clinical Trial Applications preferred.
    • Knowledge or awareness 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



    • With Director approval and in special circumstances, an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job.





    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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