Wausau & Remote Opportunities
We are a team of probiotic professionals who have dedicated our lives to the pursuit of probiotic perfection. We are industry leaders in manufacturing premium probiotic solutions.
Finished Goods Manufacturing Facility: Wausau, WI
Fermentation Facility, Sales and Marketing: Madison, WI
Global Office: Hyderabad, India
It is our mission to 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 are driven to serve our customers and our communities.
Working for UAS is not just another job. We offer the opportunity for you to create a career path. We’re committed to employee development, and pledge to provide challenges and opportunities for growth in your career.
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UAS Laboratories, LLC is seeking a Regulatory Affairs Specialist in its Wausau, WI location.
Job Description: Prepare, submit, and update regulatory dossiers and other regulatory activities related to company probiotic products and services in accordance with applicable domestic (United States) and international regulations. Provide regulatory compliance support in the areas of probiotic product registrations, labeling, artwork, advertising, product claims, etc. Focus on regulatory compliance in the U.S. Will have a working knowledge of 21 CFR Part 110, 21 CFR Part 111, and 21 CFR Part 117 as well as appropriate FDA guidance documents. Identify regulatory gaps and work to close them. Work closely with quality, research and development, sales, marketing and production departments, as well as external regulatory affairs consultants, and lead cross-functional teams ensuring regulatory compliance. Utilize excellent communication skills with the ability to clearly communicate orally and in writing. Utilize excellent planning, prioritizing and organizational skills. Utilize ability to lead cross-functional teams. Utilize ability to read and interpret regulations, guidance documents, technical manuals, handbooks, formulations, and product specifications.
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 customer products; review labeling, and promotional material related to health claims, nutrient content claims, and structure and 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 reply to regulatory inquiries; evaluate product formula changes and determine 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; utilize knowledge of Dietary Supplement Health and Education Act (DSHEA); and utilize knowledge of current FDA and FTC guidance and enforcement within the food and dietary supplement industries.
Minimum Requirements: Bachelor’s degree in Pharmacy, Microbiology, Applied Life Sciences, or a closely related degree plus five (5) years of experience in dietary supplement, food, or the pharmaceutical industry. Experience must include five (5) years of working experience of 21 CFR Parts 110, 111, and 117, FSMA, and New Dietary Ingredient guidance and one (1) year of experience with corporate software tools – Microsoft Office suite including Word, Excel and PowerPoint. Experience may be gained concurrently. Employer will accept any suitable combination of education, training, or experience. Foreign degree equivalent is accepted.
How to Apply: Please submit your resume to Jacki Gessler, 555 N. 72nd Avenue, Wasau, WI 54401.
4845-9913-9762, v. 2