The Regulatory Affairs Manager is responsible for leading, planning, managing and executing the preparation, submission and update of regulatory dossiers and other regulatory activities related to company probiotic products and services in accordance with applicable domestic (United States) and international regulations. This position helps lead regulatory compliance by providing creative solutions to regulatory challenges in the areas of probiotic product registrations, labeling, artwork, advertising, product claims, etc. The Regulatory Affairs Manager will proactively focus on regulatory compliance in the US, will have a working knowledge of 21 CFR Part 110, 21 CFR Part 111, 21 CFR Part 117 and the Food Safety Modernization Act (FSMA) and will identify regulatory gaps and work to close them. The Regulatory Affairs Manager will work closely with Quality, R&D, Sales, Marketing, and Production departments, will lead cross-functional teams ensuring regulatory compliance and will report to the Chief Scientific Officer and will be located in Madison, WI.
To perform this job successfully, an individual must be able to perform each essential job duty. Essential job functions and duties include, but are not limited to:
- Prepare and update regulatory files, those to be held internally and those to be submitted to appropriate agencies (FDA, Health Canada, and others) to allow marketing of company products and/or customer products
- Reviews labeling, publications, websites, and promotional material related to health claims, nutrient content claims, and structure/function claims to meet the requirements of FDA, FTC, and other applicable regulatory bodies
- Work cross-functionally to obtain the necessary information to prepare regulatory dossiers and/or to reply to regulatory inquiries
- Evaluates product formula changes and determines impact on existing product registrations.
- Perform the needed research on applicable regulatory guidelines in natural health products, dietary supplements, functional foods, and other sectors necessary to fulfill the job requirements
- Maintain current knowledge of regulatory standards within jurisdictions of business activity
- Provide guidance to and partner with internal stakeholders on product concepts, claims and formulations to ensure compliance with applicable legal and regulatory requirements