Manager, Regulatory Affairs El Segundo, CA

OverviewSmartyPants is seeking a compliance expert with extensive experience in the dietary supplement industry. The candidate will have a passion for supporting innovation and business processes, deep knowledge of regulatory requirements to substantiate label and marketing claims, and strong collaboration with cross-functional partners.The Regulatory Affairs Manager will lead daily end-to-end regulatory support and systems to ensure continued compliance with regulatory requirements and the growth of the SmartyPants brand. This role partners with Product Development, Quality, Sales, and Marketing to provide regulatory guidance for labeling, formula compliance, advertising, and marketing of SmartyPants products. The RA Manager serves as the Company’s operational expert on claims review, directing and informing internal stakeholders on the creation and maintenance of claims considering existing, new, and emerging regulations and enforcement initiatives. This expertise enables SmartyPants to grow as a competitive and differentiated business, with speed to market for compliant product claims. The RA Manager reports to the RA Director.The job holder is responsible for staying up to date with SOPs and current industry and regulatory guidelines and regulations.What You’ll DoCollaborate cross-functionally and provide regulatory expertise to ensure compliance with applicable FDA, FTC, and state regulationsApply risk management principles and 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 compliance with all regulatory agencies to protect the brand while driving growthEnsure consistent and compliant use of claim language across all marketing materials including label copy, web content, and marketing collateralDevelop label specifications, Supplement Fact 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 the use of ingredients, product safety, labeling and advertising to assess regulatory impactManage and track all regulatory submissions, including FDA 30-day notices for structure/function claims, and others as neededDevelop, implement, and revise SOPs, work instructions, and forms related to Regulatory Affairs operations to ensure consistency and complianceSupport product certification audits and requirements as neededInvestigate and respond to inquiries related to regulatory affairs activitiesWhat You HaveBachelor’s degree in a technical discipline such as Regulatory Affairs, Biological, Health, Nutrition Sciences, or an equivalent field5-7 years of regulatory affairs experience in an FDA-regulated industry, with a 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, 21 CFR 111Ability to collaborate cross-functionally and establish true partnerships between Marketing, Product Development, and Contract ManufacturersExcellent verbal and written communication skills (analysis, interpretation, and reasoning)Ability to exercise sound judgment and apply decision-making skillsHighly organized with strong attention to detail, able to manage multiple tasks, meet deadlines, and prioritize in a fast-paced environment while maintaining internal and external customer service and a solution-oriented approachExperience 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 and sensitive information with discretionWillingness to travel when requiredThe DetailsHours: Full time, exempt (salaried)Manager: Sr. Director, Regulatory AffairsPlease note: Candidates must be authorized to work in the United States without sponsorship.What we offerOpportunity to work with an intelligent, inspiring, and fun team100% employer-paid medical coverage for employee only, dental + ortho, and vision insurance4 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 + Cell Phone StipendsFree productAnd much more!Voluntary Self-IdentificationFor government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is voluntary and will not be considered in the hiring process. Any information provided will be confidential.As set forth in SmartyPants Vitamins’ Equal Employment Opportunity policy, we do not discriminate on the basis of protected status under applicable law.If you belong to protected veteran categories, indicate by selecting the appropriate option. As a government contractor subject to VEVRAA, we request this information to measure outreach effectiveness. Categories are defined below and include: disabled veteran, recently separated veteran, active duty wartime or campaign badge veteran, Armed Forces service medal veteran. Select if applicable.Voluntary Self-Identification of Disability: Form CC-305. Page 1 of 1. OMB Control Number 1250-0005. Expires 04/30/2026.Why are you being asked to complete this form? We are a federal contractor subject to equal employment opportunity requirements and have a goal of at least 7% of workers with disabilities. Completing this form is voluntary and confidential. For more information, visit the U.S. Department of Labor OFCCP website.Disabilities include, but are not limited to: list of disabilities follows, including examples like ADHD, autism, etc. This is a list of conditions for informational purposes only.PUBLIC BURDEN STATEMENT: This survey may take about 5 minutes to complete as part of compliance requirements. #J-18808-Ljbffr

Created: 2025-10-06