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Rahway

    Regulatory Operations Specialists - Rahway, United States - HonorVet Technologies

    HonorVet Technologies
    HonorVet Technologies Rahway, United States

    2 weeks ago

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    Description

    • Under general supervision, responsible for the preparation of high-quality labeling documents for submission to the US Food and Drug Administration (FDA).
    • Ensure that product labeling is updated in accordance with FDA regulations and corporate guidelines.
    • Ensure prompt availability of labels and artworks and liaises with departments such as Marketing, Pharmacovigilance and Technical Services to ensure compliance with established regulations.
    • Maintain databases and team sites by ensuring updated and accurate information is uploaded

    Quals Title:
    Labeling Specialist within

    Animal Health Education:
    Associate/Bachelor of Life Science/Master's degree


    Required Experience and Skills:

    • With Associate, minimum 5 years of relevant experience within pharmaceutical labeling experience
    • With Bachelor's, minimum 3 years of relevant experience within pharmaceutical labeling experience
    • With Master's minimum 2 years of relevant experience within pharmaceutical labeling experience
    • Require someone with scientific background or familiarity with medical terminology.
    • Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook, and SharePoint.
    • Excellent English oral and written communication skills and presentation skills.
    • Industry - Pharmaceutical Industry/Vaccine manufacturing/Medical and

    Biotechnology Personality:

    • Attention to details
    • Team Player
    • Can work independently
    • Excellent communication and written skills Note:
    • 1 year assignment with possibility of extension
    • Hybrid schedule (require to be onsite for 3 days/week -Tuesday and Wednesday fixed) 3rd day is optional.
    • Manager will prefer someone with experience over a degree/education.
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