Regulatory Affairs Specialist
2 days ago
The Regulatory Affairs Specialist is responsible for ensuring the accuracy and compliance of Nutrition/Supplement Facts panels and customer labels for contract formulations. This role assists the Regulatory Manager and other associates within the Regulatory Department, working closely with Product Development, Sales/Customer Service, and other internal functional areas to ensure timely submission of regulatory documentation and compliance.
Key Responsibilities:- Review and approve Dietary Supplement/Food labels for technical accuracy and compliance with all mandated regulatory requirements.
- Provide information to rectify label issues and assist in resolving issues related to the use of customers' labels for packaging.
- Assist in the creation and update of the final Supplement/Nutrition Facts Panel (SFP/NFP) for new and existing products, ensuring consistency with the master manufacturing formula and compliance with all applicable food/dietary supplement labeling regulations.
- Maintain and organize files for online and hard copy product label Master Copy books.
- Assist in gathering and reviewing raw materials documents, ensuring the minimal required documents are provided by raw material vendors on time.
- Review and approve or reject customer labels, making suggestions to rectify any errors to ensure compliance with all pertinent labeling regulations.
- Assist in and ensure the timely and accurate completion of documents (Product Data Sheet, Allergen Statement, BE/GMO statement, etc.) and other regulatory requests and inquiries from external customers and from other departments in the company related to labeling compliance, product, and ingredients information and documentation.
- BS degree in Nutrition, Life Sciences, or nutrition-related discipline with at least two years of directly related experience in Regulatory Affairs within the food/dietary supplement manufacturing industry.
- Knowledge of Dietary Supplement GMP guidelines and specific GMP documentation guidelines.
- Familiarity with food/dietary supplement ingredients and formulas.
- Knowledge of food/dietary supplement nutrition labeling regulations, including FDA nutrition labeling regulations.
- Conversant with regulatory guidelines for food/dietary supplements and familiarity with food/dietary supplement ingredients, formulas, and manufacturing processes.
- Understand and interpret FDA regulations for nutritional labeling, rounding rules, percent daily values, and other applicable technical/regulatory information for food/dietary supplements.
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
1 month ago
Stamford, Connecticut, United States Vital Health America LLC Full timeJob SummaryThe Regulatory Affairs Specialist is a key member of the Vital Health America LLC team, responsible for ensuring compliance with all regulatory requirements related to food and dietary supplement labeling. This role involves creating, reviewing, and implementing Nutrition/Supplement Facts panels and customer labels for contract formulations.Key...
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Regulatory Affairs Specialist
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Stamford, Connecticut, United States Vital Health America LLC Full timeJob SummaryThe Regulatory Affairs Specialist is a critical role within Vital Health America LLC, responsible for ensuring compliance with all regulatory requirements related to food and dietary supplement labeling. This position plays a key role in the creation, development, review, and implementation of Nutrition/Supplement Facts panels and customer labels...
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