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    Regulatory Specialist - St Paul, United States - Bell International Laboratories

    Bell International Laboratories
    Bell International Laboratories St Paul, United States

    3 weeks ago

    Default job background
    Customer Service / Support
    Description

    The Regulatory Compliance Specialist, within the Quality Assurance department, is a dedicated professional who ensures adherence to regulatory compliance aligned with cGMP and current requirements. This individual aids in the day-to-day quality management activities within Bell Labs, ensuring alignment with both company and regulatory requirements.

    Responsibilities

    • Support our customers through provision of requested regulatory documentation.
    • Coordinate and prepare routine submissions for FDA and other regulatory entities.
    • Monitor applicable regulatory requirements to assure compliance with domestic and foreign regulatory standards.
    • Maintain regulatory approvals and associated files. Build and maintain "regulatory library".
    • Provide regulatory feedback to R&D regarding proposed product ingredient lists.
    • Evaluate customer artwork for adherence to regulatory compliance.
    • Support R&D during development process to ensure formulas are compliant in the applicable regulated countries.
    • Identify and create efficiencies in the facilitation of regulatory processes.
    • Actively participate in internal audits, customer audits and other activities as assigned by manager.

    Required Skills/Abilities

    • Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines.
    • Ability to effectively build and maintain relationships, communicating and interacting in a matrix environment.
    • Strong organizational skills, with a keen eye for reviewing and editing documents.
    • Ability to maintain meticulous attention to detail and precision while juggling multiple tasks.
    • Excellent written, verbal and interpersonal communication skills
    • Proficiency in Microsoft Office and Adobe Acrobat

    Required Education and Experience

    • BS/BA in science, engineering, quality/regulatory studies, or equivalent industry experience in pharmaceutical regulatory affairs.
    • A quality professional with 2-5 years of hands-on experience in regulatory management within the regulated pharmaceutical industry, including direct regulatory experience.

    Preferred Education and Experience

    • Exhibit a quality mindset and a willingness to develop yourself and others.
    • Demonstrated knowledge of GMPs, 21 CFR 210 and 211 and other regulatory agency requirements sufficient to apply to quality operations and compliance.
    • Audit or inspection experience preferred.
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