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Rahway

    Regulatory Specialist - Rahway, United States - iConsultera

    iConsultera
    iConsultera Rahway, United States

    3 weeks ago

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    Description

    Title: Labeling Specialist

    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.

    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

    Intake notes:

    Hybrid schedule

    Experience would be preferred over a degree.

    Looking for someone with labeling expertise in the pharmaceutical industry, vaccines manufacturing or GMP.

    Software: MS office

    Typical day:

    Very intensive label-oriented job

    Need someone to hit the ground running.

    Lot of label review and submission.

    Quality check for label content and formatting as per FDA guidelines.

    Support the team with the review, revising labeling.

    Attention to details.

    Will review labels on packaging, container, carton boxes.

    Will prepare the label content following SOPs and FDA regulations.

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