Manager, Regulatory Affairs

OverviewSmartyPants is looking for a compliance expert with significant experience in the dietary supplement industry, passionate about supporting innovation and business processes. This role requires extensive knowledge of regulatory requirements to substantiate label and marketing claims, strong attention to detail, solution orientation, excellent communication, and collaboration with cross-functional partners.What You’ll DoCollaborate cross-functionally and provide regulatory expertise to ensure compliance with applicable FDA, FTC, and state regulationsApply risk management principles and deep regulatory insight to solve problems and identify compliant solutions as a proactive business partner throughout the product lifecycleDevelop and maintain regulatory substantiation files, ensuring adequate substantiation for product and ingredient claims and regulatory complianceEnsure consistent and compliant use of claim language across all marketing materials including label copy, web content, and marketing collateralDevelop label specifications, Supplement Facts Panels, and ingredient/allergen statements in compliance with applicable regulationsOversee the review/approval of labels, supplement facts panels, formulas, and ingredients for regulatory complianceProvide regulatory support for SmartyPants innovation pipelineCreate and maintain product regulatory dossiers/databaseStay current with developing laws, regulations and enforcement activities impacting ingredients, product safety, labeling and advertisingManage and track regulatory submissions, including FDA 30-day notices for structure/function claims, and other required filingsDevelop, implement, and revise SOPs, Work Instructions, and forms as they pertain to Regulatory Affairs operationsSupport product certification audits and requirements as neededInvestigate and respond to inquiries related to regulatory affairs activitiesWhat You HaveBachelor’s degree in Regulatory Affairs, Biological, Health, Nutrition Sciences, or equivalent5–7 years of regulatory affairs experience in an FDA-regulated industry, with strong preference for dietary supplement experienceExperience in conducting label and marketing reviews, developing claim substantiation for dietary supplements, and supporting innovationExtensive knowledge of FDA, FTC, and USDA regulatory requirements for dietary supplements and foodsExperience with dietary supplement GMPs and 21 CFR 111Ability to collaborate cross-functionally and establish partnerships across Marketing, Product Development, and Contract ManufacturersExcellent verbal and written communication skillsStrong judgment and decision-making abilitiesHighly organized with critical attention to detail; able to manage multiple tasks in a fast-paced environmentExperience with foreign regulatory agencies and international regulations is a plusProfessional, positive, and approachable demeanorGeneral project management skills and knowledge of the product development process is a plusAbility to handle confidential information with discretionWillingness to travel as requiredThe DetailsHours: Full time, exempt (salaried)Manager: Sr. Director, Regulatory AffairsNote: Candidates must be authorized to work in the United States without sponsorship.What we offerOpportunity to work with a smart, collaborative team100% employer-paid medical coverage for employee only, dental & vision4 weeks PTO + paid holidays + 12 Mental Health Days per year100% Paid parental leave, Fertility & Adoption BenefitsAnnual Bonus Plan401(k) plan with employer matchHybrid work, wellness benefits, and stipendsFree productAnd moreAbout UsWe are SmartyPants Vitamins – the best-selling vitamin and supplement brand known for high-quality, nutrient-dense gummies for the whole family. In 2020 we joined Unilever as part of the Health & Wellbeing Collective, expanding support for growth globally. SmartyPants values family, authenticity, and collective well-being, delivering best-in-class products that taste great.Voluntary Self-IdentificationFor government reporting purposes, candidates may respond to the self-identification survey. Completion is voluntary and will not affect hiring. Any information provided will be confidential. We are an equal opportunity employer and do not discriminate against protected groups.Voluntary disabilities information: this form is part of government contractor requirements and is optional. Your responses are confidential and used for compliance reporting. For details, see applicable OFCCP guidance. #J-18808-Ljbffr

Created: 2025-10-06