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Rahway

    Regulatory Specialist - Rahway, United States - iConsultera

    iConsultera
    iConsultera Rahway, United States

    2 weeks ago

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    Description

    Title: Labeling Specialist

    • Under supervision, responsible for preparing labeling documents for submission to the US FDA.
    • Ensure product labels comply with FDA regulations and company guidelines.
    • Ensure timely availability of labels, collaborate with Marketing, Pharmacovigilance, and Technical Services for compliance.
    • Maintain updated databases and team sites.

    Education: Associate/Bachelor/Master's in Life Science.

    Required Experience and Skills:

    • Associate: 5 years in pharmaceutical labeling.
    • Bachelor's: 3 years in pharmaceutical labeling.
    • Master's: 2 years in pharmaceutical labeling.
    • Background in science or medical terminology.
    • Proficient in MS Office, Excel, Word, Outlook, and SharePoint.
    • Strong English oral and written communication skills.
    • Industry experience in Pharmaceutical/Vaccine manufacturing/Biotechnology.

    Intake notes:

    • Hybrid schedule.
    • Experience preferred over a degree.
    • Seeking expertise in pharmaceutical labeling, vaccines, or GMP.

    Software: MS Office

    Typical day:

    • Intensive label-focused role.
    • Fast-paced environment, requires quick adaptation.
    • Review and submit labels, ensure FDA compliance.
    • Assist team in label revision and review.
    • Attention to detail.
    • Review labels on packaging and containers.
    • Prepare label content following SOP's and regulations.
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