• Director of International Regulatory Affairs

    Job Locations US-AZ-Gilbert
    Job ID
    2018-2330
    Category
    QRTS
  • Position Summary

    The position is responsible for the applied ingredients and regulatory compliance for products with a focus on international documentation requirements. The Director of International Regulatory Affairs will manage various projects, including formula and label reviews, product registration claims and direct the work associated with obtaining government approval for product imports into international markets.

    Essential Duties & Responsibilities (Other duties may be assigned)

    • Direct team of Regulatory professionals in the execution of submission and registrations strategies for dietary supplements, foods, and cosmetic product.
    • Manage the regulatory compliance of products, labels, advertising and promotions as well as adherence to Isagenix policies and guidelines.
    • Identify and maintain procedures for the registration and exporting of ingredients and products into assigned markets.
    • Review and ensure compliance and technical accuracy with formulation, label graphics and ingredient claims.
    • Interact with cross-functional staff across various business units, partners, contractors, lawyers and government entities to support effective product registration and launch in assigned markets.
    • Partner with R&D and other business teams to identify export processing and workflow opportunities.
    • Stay abreast of international regulatory developments and identify opportunities and/or implications to the business.
    • Maintain accurate and up-to-date regulatory records and databases.
    • Independently manage complex issues and problems and keep management informed of more complex issues.
    • Develop and apply a comprehensive understanding of the global regulatory regulations and guidelines for products to enhance probability of regulatory success and regulatory compliance.
    • Possess solid working knowledge of subject matter.
    • Provide leadership, coaching, and/or mentoring to subordinate group.

    Minimum Qualifications (These are the requirements that all applicants MUST HAVE to be considered for this position)

    • Bachelor’s Degree from an accredited institution or equivalent experience.
    • 8 years of experience in a regulatory affairs or product development position.
    • 4 years of experience leading high performing teams.
    • Skilled in the use of Microsoft office software to include Word, Excel, PowerPoint, and Outlook.
    • Strong interpersonal skills, detail oriented and able to coordinate/manage multiple tasks simultaneously.
    • Possess an expert understanding of associated best practices.
    • Ability to understand, assess & problem solve by leveraging technical and analytical skills.
    • Ability to work/communicate with all levels of the organization.
    • Develop collaborative and diverse relationships.
    • High customer focus with the ability to drive for results.

    Preferred Qualifications

    • Bachelor’s Degree in food science, chemistry, biology or related technical field.
    • 10 years of experience in a regulatory affairs or product development position.
    • Experience in the food or pharmaceutical industry.

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