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Regulatory Compliance Manager - Dietary Supplements

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Regulatory Compliance Manager - Dietary Supplements

Los Angeles, CA
Full Time
Paid
  • Responsibilities

    Position Description: The Regulatory Compliance Manager will serve as the regulatory expert in helping keep the company compliant with all regulatory laws pertaining to the food and dietary supplements industry. This role will also provide guidance on product labelling, claim substantiation, and raw material compliance to name a few.

    Responsibilities:

    1. Serves as regulatory expert on product development and product label creation.
    2. Reviews technical data to ensure accuracy on all supplement and nutritional fact panels.
    3. Ensures all product packaging are in compliance with U.S. labeling regulations.
    4. Maintains external references, lists of national and international regulation standards and FDA guidance documents that affect the product labeling.
    5. Provides technical assistance on various department tasks and projects as needed.
    6. Provides regulatory guidance and answers compliance-related questions regarding new and reformulated product concepts
    7. Ensures all product information and labelling are accurate.
    8. Works with Procurement to ensure raw materials and contract-manufactured products are in compliance with composition and labelling.
    9. Works with R&D and Marketing on claims and claim substantiation.
    10. Monitors and ensures website advertising content is consistent and in compliance.
    11. Identifies and provides resolution to strategic and tactical regulatory issues pertaining to food labeling.
    12. Advises business regarding current and emerging food labeling issues and opportunities and its impact on products and product technology.
    13. Stays up to date on FDA regulations and policies.
    14. Oversees the Regulatory Affairs requirements of both ingredients and finished products.
    15. Prepares and/or oversees production of documents required for approval of new ingredients (NDIs) and safety reviews (GRAS).
    16. Prepares 403(r)(6) structure/function claim submissions to the FDA.
    17. Performs any other related duties as may be required.

    Job Requirements:

    Ø Minimum of a BA Degree in Food Science, Nutrition, Food Law or related field. Ph.D or JD preferred.
    Ø 3+ years of relevant labeling experience in the food/supplement industry.
    Ø Must have a strong understanding of FDA regulations and ability to provide strategic guidance in the food/supplement industry.
    Ø Must be knowledgeable of U.S. labeling and quality regulations for dietary supplements and food.
    Ø Must have strong research and communication skills.
    Ø Must be proficient with Word and Outlook
    Ø Must have strong attention to detail
    Ø Must be a team player.