Regulatory Affairs Specialist

4 weeks ago


Stamford, Connecticut, United States Vital Health America LLC Full time
Job Summary:

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.
Requirements:
  • 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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