Manager, Regulatory Affairs

Position Overview:

SmartyPants is looking for a compliance expert with years of experience in the dietary supplement industry and has a passion for supporting innovation and business processes. This person has extensive knowledge of regulatory requirements to make substantiated label and marketing claims, is extremely detail- and solution oriented, has excellent communication skills and loves to collaborate with cross-functional partners.

The Regulatory Affairs Manager will lead daily end-to-end regulatory support and systems to ensure continued compliance with established regulatory requirements and the growth and success of the SmartyPants brand. This role will partner with Product Development, Quality, Sales, and Marketing teams to provide regulatory guidance for labeling, formula compliance, advertising, and marketing of SmartyPants products. The RA Manager will serve as the Company's operational expert on claims review, providing direction and insights to appropriate internal stakeholders on the creation and maintenance of claims with regards to existing, new, and emerging regulations as well as enforcement initiatives. This expertise will enable SmartyPants to continue to grow as a competitive and differentiated business, enabling speed to market with competitive and compliant product claims. The RA Manager reports directly to the RA Director.

The job holder is responsible for keeping up to date with SOPs and current industry and regulatory guidelines and regulations.

What You’ll Do:

• Collaborate cross-functionally and provide regulatory expertise, to ensure compliance with applicable FDA, FTC, and state regulations
• Use risk management principles and deep regulatory insight to solve problems and identify compliant solutions as a proactive business partner throughout the product’s lifecycle
• Develop 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 growth
• Ensure consistent/compliant use of claim language across all marketing materials including label copy, web content, and marketing collateral
• Develop label specifications, Supplement Fact 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
• Keep current with developing laws, regulations and enforcement activities impacting the use of ingredients, product safety, labeling and advertising to provide effective regulatory assessment and impact of proposed changes to the business
• Manage and track all regulatory submissions, including FDA 30-day notices for structure/function claims, and others as needed, are filed
• Develop, implement, and revise SOPs, Work Instructions, and forms, as needed, as they pertain to the Regulatory Affair operations to ensure consistency and compliance
• Support product certification audits and requirements as needed
• Investigate and respond to inquiries related to RA activities

What You Have:

• Bachelor’s degree in Technical Discipline such as Regulatory Affairs, Biological, Health, or Nutrition Sciences or an equivalent field is required.
• 5-7 years of regulatory affairs experience in an FDA-regulated industry, with a strong preference for dietary supplement experience.
• Experience in conducting label and marketing reviews, developing claim substantiation for dietary supplements, and supporting innovation
• An extensive knowledge of FDA, FTC, and USDA’s regulatory requirements & compliance in dietary supplements and foods
• Experience with dietary supplement GMPs, 21 CFR 111 required
• Ability to collaborate cross-functionally and establish true partnerships between multiple departments, particularly with Marketing, Product Development, and Contract Manufacturers
• Excellent verbal and written communication skills (including analysis, interpretation, and reasoning)
• Ability to exercise sound judgment and apply decision-making skills.
• Highly organized with critical attention to detail, able to handle multiple tasks, meet deadlines, and prioritize assignments in a fast-paced environment with changing priorities, while maintaining a focus on internal and external customer service and being solution-oriented.
• Experience with foreign regulatory agencies and international regulations a plus
• Consistently demonstrates professional, positive, and approachable attitude/demeanor.
• General project management skills and knowledge of product development process a plus
• Demonstrated ability to handle confidential and sensitive information with discretion.
• Willingness to travel when required

The pay range for this position is $113,850.00 - $139,150.00. SmartyPants Vitamins takes into consideration a wide range of factors that are utilized in making compensation decisions including, but not limited to, skill sets, experience and training, licensure and certifications, qualifications and education, and other business and organizational needs. This position is bonus eligible. SmartyPants Vitamins employees are eligible to participate in our benefits plan. Should the employee choose to participate, they can choose from a range of benefits to include, but is not limited to, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, sick leave, paid vacation and holidays. Any coverages for health insurance will be in accordance with the terms and conditions of the applicable plans and associated governing plan documents.   

About Us: 

We are SmartyPants Vitamins – the best-selling vitamin and supplement brand known for making high-quality, nutrient-dense, unbelievably delicious gummy multivitamins for the whole family. In 2020 we joined Unilever as part of the Health & Wellbeing Collective, yielding additional support as we continue to grow the brand globally. From the start, SmartyPants Vitamins has been about family, authenticity and a core commitment to our collective well-being.  SmartyPants believes in making it easier to stay healthy by providing best-in-class products that also taste great.   

We're industry leaders in testing, transparency, and advocacy, from sourcing the highest-quality ingredients to testing and packaging.  We have an appreciation for the comedy and intensity that comes from working in a company with explosive growth and a strong sense of social responsibility. 

Our mission is to bring better health to the real world. How? By making premium products that are crafted to fit delightfully into the lives of real families, and by giving back to women and children in need with the help of our partners at Vitamin Angels. With over 27MM nutrient grants donated to date, and happy customers all over the world, we are well on our way to accomplishing our goal. 

WHAT TO EXPECT DURING THE INTERVIEW PROCESS 

• Initial video screen with a member of our Talent team 
• Round 1: Conversation with the Hiring Manager + 1-2 conversations with other team members
• Round 2: 2-3 conversations with team or cross-functional partners 
• Final Round: Homework* 

*Our final round is called Homework. Candidates who participate in this round are given 3 questions in advance to answer and present to the interview panel they previously spoke with in the process. We understand every candidate is different. If you need a reasonable accommodation to adjust this procedure, please let us know as possible so that we can evaluate and provide other options that work for your needs 

THE DETAILS 

LOCATION: El Segundo, CA

 HOURS: Full time, exempt (salaried) 

MANAGER: Sr. Director, Regulatory Affairs

PLEASE NOTE: Candidates must be authorized to work in the United States without sponsorship. 

What we offer: 

• An opportunity to work with an intelligent, inspiring, and extraordinarily fun team 
• 100% employer-paid medical coverage for employee only, dental + ortho, and vision insurance 
• 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 + Cell Phone Stipends 
• Free product 
• And much more!