Regulatory Operations Specialists

3 weeks ago

Rahway, United States Intelliswift Full time

Regulatory Operations Specialists - II (Associate) Job ID: 24-02608 Qualifications: Title: Labeling Specialist 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. Responsibilities: * 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. Comments/Special Instructions * 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 SOP's and FDA regulations. * Job details *

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    5 days ago

    Rahway, United States Experis Full time

    Our client, one of the largest pharmaceutical companies in the U.S., is looking for a Regulatory Operations Specialists which is Rahway, NJ. Job Title: Regulatory Operations Specialists Location: Rahway, NJ Pay rate: $26/HR Qualifications:Education Requirements: Bachelor's degree in a relevant discipline such as animal science, veterinary technology,...

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    2 days ago

    Rahway, United States Pyramid Consulting, Inc Full time

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    9 hours ago

    Rahway, United States Pyramid Consulting Full time

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  • Regulatory Operations Specialists

    2 days ago

    Rahway, United States Pyramid Consulting, Inc Full time

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    4 days ago

    Rahway, United States HonorVet Technologies Full time

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    Rahway, United States Integrated Resources Full time

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    Rahway, United States Intelliswift Software Inc Full time

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    Rahway, United States eTeam Full time

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    1 week ago

    Rahway, United States Pyramid Consulting, Inc Full time

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    Rahway, United States Net2source Full time

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    3 weeks ago

    Rahway, United States Net2Source Inc. Full time

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    3 weeks ago

    Rahway, United States Net2Source Inc. Full time

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