Hikma Pharmaceuticals USA Inc.

  • Regulatory Affairs Assoc

    Job Location US-NJ-Eatontown
    Posted Date 4 days ago(8/10/2018 11:56 AM)
    Job ID
    2018-4710
    Job Function
    Regulatory Affairs
  • Overview

    Responsible for all activities related to product labeling. File all FDA-required documentation for approval and maintenance of IND/ANDA/NDA products.

    This position reports directly to the Manager, Regulatory Affairs.

    Responsibilities

    • Labeling review and approval for Hikma Eatontown, Hikma Jordan and 3rd parties
    • SPL submissions
    • Drug listings
    • Coordinate, prepare and publish submissions, supplements and postmarketing reports for Hikma Eatontown, Hikma Jordan and Hikma Portugal
    • Prepare information and coordinate documentation from respective departments to respond to FDA deficiency letters
    • Support local Pharmacovigilance activities
    • Additional tasks as required by Management

    Qualifications

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

    • Bachelors Degree in science-related field
    • 5 years Pharmaceutical or related experience, preferably in FDA-regulated industry
    • Experience interfacing with the FDA
    • Strong technical writing and oral communication skills
    • Knowledge of FDA guidelines and CFR
    • Strong proofreading skills
    • Word, Excel, Outlook experience
    • Electronic submission experience, SPL software experience a plus

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