Hikma Pharmaceuticals USA Inc.

  • Analyst II Drug Regulatory Affairs

    Job Location US-OH-Columbus
    Posted Date 7 days ago(8/7/2018 11:36 AM)
    Job ID
    2018-4624
    Job Function
    Regulatory Affairs
    Shift
    1st
  • Overview

    Supports both their individual and overall departmental goals regarding the number of ANDAs to be filed and approved yearly by planning, compiling, and assuring the quality of Abbreviated New Drug Applications (ANDAs) that are filed on time and responding to subsequent deficiencies completely and on time.

    Responsibilities

    • Prepares and submits Annual Reports to comply with FDA requirements.
    • Compiles and submits Abbreviated New Drug Applications (ANDA’s) to support business filing requirements.
    • Reviews and researches FDA guidances to increase knowledge as it relates to regulatory.
    • Manages multiple projects with appropriate supervision.
    • Attend educational courses and seminar to expand knowledge on regulatory guidelines.
    • Negotiates internally to help formulate appropriate response.
    • Clarifies FDA questions when necessary.
    • Manages product life-cycle changes.
    • All other duties as assigned.

    Qualifications

    • Bachelor's degree required in a scientific field.
    • Pharmaceutical experience 2-5 years preferably in a regulatory or laboratory environment (real world practical knowledge in the pharmaceutical industry).
    • Should possess professional experience in scientific document preparation, utilizing strengths in writing, organizational skills and attention to detail.

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