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
The appropriate knowledge, skills and abilities required for this position are achievable through the following combination of education, work experience and training:
Bachelor’s degree or higher, preferably in life sciences
Minimum 5 years (7-10 years preferred) of experience in dietary supplement, food or pharmaceutical industry
Certification in regulatory affairs (preferred)
Dietary Supplement Health and Education Act (DSHEA)
Current FDA and FTC guidance and enforcement within the food and dietary supplement industries
Working knowledge of 21 CFR Parts 110 ,111 and 117, FSMA, and New Dietary Ingredient guidance
Probiotics and/or microbiology (preferred)
Excellent communication skills with the ability to clearly communicate orally and in writing
Excellent planning, prioritizing and organizational skills
Ability to understand and interpret clinical trial reports, medical journal articles and other medical/scientific materials that support product claims
Ability to lead cross-functional teams
Ability to manage external resources
Demonstrated ability to be proactive, independent, highly motivated, and effective in managing multiple projects
Ability to read and interpret regulations, guidance documents, technical manuals, handbooks, formulations, and product specifications
Highly proficient with corporate software tools - Microsoft office suite including Word, Excel, PowerPoint
Additional Salary Information: Salary will be commensurate with experience
Since 1979, we have manufactured premium probiotics in the United States. It’s all we do, it’s all we have ever done. Our state-of-the-art facility is one of the few facilities in the world solely dedicated to the manufacturing of probiotic solutions. This passion for probiotic perfection not only allows us to create an optimal environment for probiotic viability, it also makes us experts in the f...ield. From pharmacists, to food scientists, to biochemists, PhDs, and nutritionists, our combined experience in probiotic management totals over 100 years.
Our commitment to superior probiotic products goes further than just our facility. UAS Labs continually invests in gold-standard clinical trials on not only individual probiotic strains, but finished private label formulations as well. We believe investing in clinical research means investing in the health of your customers. All of our trials are led by one of the world’s foremost probiotic experts, Dr. Greg Leyer, PhD, who is also our Chief Scientific Officer. Dr. Leyer and his team of top scientists ensure that the products you receive are the a result of the latest scientific research and top of the line technology.
Let us show you why our experience, expertise, and capabilities make UAS Labs the most trusted name in the probiotic industry.
We will provide leading and trusted probiotic based solutions through the creative application of science, quality and talent that promote healthy living, while exceeding stakeholder expectations.
We strive to enhance wellness and quality of life through innovative probiotic solutions.