SmartyPants Vitamins
Manager, Regulatory Affairs
SmartyPants Vitamins, El Segundo, California, United States, 90245
Overview
SmartyPants 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 Do
Collaborate cross-functionally and provide regulatory expertise to ensure compliance with applicable FDA, FTC, and state regulations Apply risk management principles and deep regulatory insight to solve problems and identify compliant solutions as a proactive business partner throughout the product lifecycle Develop and maintain regulatory substantiation files, ensuring adequate substantiation for product and ingredient claims and regulatory compliance Ensure consistent and compliant use of claim language across all marketing materials including label copy, web content, and marketing collateral Develop label specifications, Supplement Facts Panels, and ingredient/allergen statements in compliance with applicable regulations Oversee the review/approval of labels, supplement facts panels, formulas, and ingredients for regulatory compliance Provide regulatory support for SmartyPants innovation pipeline Create and maintain product regulatory dossiers/database Stay current with developing laws, regulations and enforcement activities impacting ingredients, product safety, labeling and advertising Manage and track regulatory submissions, including FDA 30-day notices for structure/function claims, and other required filings Develop, implement, and revise SOPs, Work Instructions, and forms as they pertain to Regulatory Affairs operations Support product certification audits and requirements as needed Investigate and respond to inquiries related to regulatory affairs activities What You Have
Bachelor’s degree in Regulatory Affairs, Biological, Health, Nutrition Sciences, or equivalent 5–7 years of regulatory affairs experience in an FDA-regulated industry, with strong preference for dietary supplement experience Experience in conducting label and marketing reviews, developing claim substantiation for dietary supplements, and supporting innovation Extensive knowledge of FDA, FTC, and USDA regulatory requirements for dietary supplements and foods Experience with dietary supplement GMPs and 21 CFR 111 Ability to collaborate cross-functionally and establish partnerships across Marketing, Product Development, and Contract Manufacturers Excellent verbal and written communication skills Strong judgment and decision-making abilities Highly organized with critical attention to detail; able to manage multiple tasks in a fast-paced environment Experience with foreign regulatory agencies and international regulations is a plus Professional, positive, and approachable demeanor General project management skills and knowledge of the product development process is a plus Ability to handle confidential information with discretion Willingness to travel as required The Details
Hours: Full time, exempt (salaried) Manager: Sr. Director, Regulatory Affairs Note: Candidates must be authorized to work in the United States without sponsorship. What we offer
Opportunity to work with a smart, collaborative team 100% employer-paid medical coverage for employee only, dental & vision 4 weeks PTO + paid holidays + 12 Mental Health Days per year 100% Paid parental leave, Fertility & Adoption Benefits Annual Bonus Plan 401(k) plan with employer match Hybrid work, wellness benefits, and stipends Free product And more About Us
We 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-Identification
For 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.
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SmartyPants 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 Do
Collaborate cross-functionally and provide regulatory expertise to ensure compliance with applicable FDA, FTC, and state regulations Apply risk management principles and deep regulatory insight to solve problems and identify compliant solutions as a proactive business partner throughout the product lifecycle Develop and maintain regulatory substantiation files, ensuring adequate substantiation for product and ingredient claims and regulatory compliance Ensure consistent and compliant use of claim language across all marketing materials including label copy, web content, and marketing collateral Develop label specifications, Supplement Facts Panels, and ingredient/allergen statements in compliance with applicable regulations Oversee the review/approval of labels, supplement facts panels, formulas, and ingredients for regulatory compliance Provide regulatory support for SmartyPants innovation pipeline Create and maintain product regulatory dossiers/database Stay current with developing laws, regulations and enforcement activities impacting ingredients, product safety, labeling and advertising Manage and track regulatory submissions, including FDA 30-day notices for structure/function claims, and other required filings Develop, implement, and revise SOPs, Work Instructions, and forms as they pertain to Regulatory Affairs operations Support product certification audits and requirements as needed Investigate and respond to inquiries related to regulatory affairs activities What You Have
Bachelor’s degree in Regulatory Affairs, Biological, Health, Nutrition Sciences, or equivalent 5–7 years of regulatory affairs experience in an FDA-regulated industry, with strong preference for dietary supplement experience Experience in conducting label and marketing reviews, developing claim substantiation for dietary supplements, and supporting innovation Extensive knowledge of FDA, FTC, and USDA regulatory requirements for dietary supplements and foods Experience with dietary supplement GMPs and 21 CFR 111 Ability to collaborate cross-functionally and establish partnerships across Marketing, Product Development, and Contract Manufacturers Excellent verbal and written communication skills Strong judgment and decision-making abilities Highly organized with critical attention to detail; able to manage multiple tasks in a fast-paced environment Experience with foreign regulatory agencies and international regulations is a plus Professional, positive, and approachable demeanor General project management skills and knowledge of the product development process is a plus Ability to handle confidential information with discretion Willingness to travel as required The Details
Hours: Full time, exempt (salaried) Manager: Sr. Director, Regulatory Affairs Note: Candidates must be authorized to work in the United States without sponsorship. What we offer
Opportunity to work with a smart, collaborative team 100% employer-paid medical coverage for employee only, dental & vision 4 weeks PTO + paid holidays + 12 Mental Health Days per year 100% Paid parental leave, Fertility & Adoption Benefits Annual Bonus Plan 401(k) plan with employer match Hybrid work, wellness benefits, and stipends Free product And more About Us
We 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-Identification
For 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.
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