Regulatory Manager-235408
Medixâ„¢ - Congers, NY
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We are currently hiring for a Regulatory Manager at a flavor manufacturing and formulation company in Congers, NY that primarily serves the food and beverage industry! This role is hybrid (2 days onsite) with a flexible schedule!The Regulatory Manager creates and reviews a wide range of regulatory documentation to ensure compliance with FDA regulations and customer agreements as well as manages the raw material approval and information maintenance process. The Regulatory Manager is part of the regulatory team which ensures the accuracy and consistency of product documentation and databases. The position supports the Directory of Regulatory Affairs to manage resources and create policies for regulatory compliance. This position is responsible for helping to ensure that all actions of the company adhere to local, state, and national rules and laws that govern.**Manages vendor approvals.Reviews and approves raw materials and finished products while maintaining internal documentation and databases. (e.g. Genesis, SAGE X3 ERP, shared documents etc.).Generates, reviews and maintains finished product documentation and databases.Completes and reviews customer submission materials to ensure timeliness, accuracy and comprehensiveness.Manages and maintains customer document share websites.Reviews, approves and maintains customer specifications.Provides regulatory support and guidance for external and internal customers.Authors and approves regulatory policies and procedures.Maintains current knowledge of and compliance with FDA regulations.Maintains current knowledge of and necessary documentation for certifications and claims (Kosher, Halal, Fair Trade, Non-GMO, Vegan, Dairy Free, etc.).Participates in food safety and quality improvement initiatives.Manages relationships with business partners where work is outsourced.Assists with researching regulatory requirements.Assists with vendor document maintenance.Assists with process improvement initiatives and complaint investigations as required.Bachelors Degree (BA) from four-year college or university (preferably in a related field)Food Law Knowledge and *** 21CFR Parts 1 -199, 7CFR66 and other applicable parts, Food Standards of Identity, Food Labeling, Nutrition Calculations, BE regulation5-10 years working experience in Food Regulatory
Created: 2024-11-01