Hikma Pharmaceuticals USA Inc.

  • Regulatory Affairs Associate

    Job Location US-NJ-Cherry Hill
    Posted Date 1 week ago(10/12/2018 6:24 PM)
    Job ID
    2018-4833
    Job Function
    Regulatory Affairs
    Shift
    Cherry Hill First Shift
  • Overview

    Responsible for the preparation of ANDAs, amendments, and supplement applications to OGD and FDA for approval, which includes responding to any deficiency letters related to ANDA submissions.

    Responsibilities

    1. Completes regulatory portion of Annual Product Reviews (APRs).
    2. Reviews Change Control Requests (CCRs) and provides regulatory opinion with supervisor concurrence.
    3. Participates in multidisciplinary project teams for new products site CMC support.
    4. Provides regulatory advice to teams and gives updates at regulatory staff meetings as needed.
    5. Prepares annual reports, supplements, amendments, and other correspondences.
    6. Participates and becomes involved with various tasks force teams, as designated by the manager and will act as regulatory liaison to specially assigned R & D and site project teams.
    7. Reviews labeling for new products and revisions for existing products.
    8. Proofreads labeling drafts as requested by labeling.

    Qualifications

    BS degree in a scientific discipline with 2 to 5 years' experience in the Pharmaceutical Industry along with excellent

    communication skills is required. Two (2) years of regulatory exposure is preferred.

    1. Exercise independent judgment.
    2. Scientific knowledge.
    3. Written and Verbal communication skills.
    4. Strong Negotiation skills.
    5. Technical system skills (e.g. word processing, spreadsheets, databases, online research).
    6. Manage multiple projects and deadlines.
    7. Ability to identify compliance risks and escalate when necessary.

     

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