Temporary Regulatory Affairs Specialist
Position Overview:
The job holder maintains SmartyPants Regulatory Affairs (RA) systems to assure the continued conformity of SPV compliance with established regulatory requirements. Demonstrates the behavior of thoroughness, results orientation, adaptability, tenacity and initiative. The job holder is responsible for keeping up-to-date with SOPs and current industry and regulatory guidelines and regulations.
What You’ll Do:
- Act as a Regulatory Affairs representative for SmartyPants.
- Work with the Director of RA to:
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- Provide regulatory support for new product development and current commercially marketed products: Create and maintain product regulatory dossiers/database to ensure all claims for labels, websites, sales/marketing materials are adequately substantiated, approved, controlled, and in compliance with regulatory requirements.
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- Review and approve labels for Regulatory compliance.
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- Review Marketing materials for Regulatory compliance.
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- Ensure all ingredients and blends meet regulatory requirements and are approved for use in commercial production.
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- Ensure SPV products are in compliance with all Prop 65 requirements.
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- Certify products with various 3rd party certification bodies for USDA Organic, Non-GMO, Kosher, etc.
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- Collaborate with Nutrition Science to create and maintain Claims Dossiers. Assess and review peer-reviewed studies, clinical studies, and other supporting literature for product claims.
- Research regulations and guidelines to provide effective regulatory assessment of proposed changes to products and claims.
- Create SOPs and forms, as required to define the regulatory process.
- Compose cover letters and summaries, assemble/format submissions, for external regulatory requests/requirements as necessary.
- Inform other departments on new regulatory developments.
- Perform regulatory vigilance to ensure any regulatory changes applicable to SPV current products/claims are evaluated and if required, implemented.
- Other duties as needed in the RA department
What You Have:
- Bachelor’s degree in a technical discipline (e.g., Biology, Chemistry, Nutrition Science, Microbiology) with at least 3 years of experience in the dietary supplement industry.
- Must be knowledgeable and up-to-date with GMPs and regulations.
- Ability to exercise sound judgment and decision-making skills.
- Preferred experience in Risk Management, claims substantiation, and partnering with R&D, Operations, Marketing, and CMOs.
- Experience in reviewing ingredients and labels is required.
- Proficiency in standard business software (Microsoft), including database management and report generation.
- Excellent organizational skills, capable of handling multiple tasks, meeting deadlines, and prioritizing assignments with a customer service focus.
- Superior written and verbal communication skills, with the ability to interact and gain management support.
- Ability to manage multiple, complex priorities and work cooperatively in diverse teams.
- Meticulous attention to detail, including proofreading skills.
- Professional, positive, and approachable demeanor, demonstrating common sense, flexibility, teamwork, and discretion in handling confidential information.
- Excellent interpersonal skills; ability to interact with all personality types and behaviors; flexibility
- Ability to work effectively in a high-pressure, fast paced environment
What you’ll get:
The pay range for this position is $44.00/hr to $50.00/hr. 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 a temporary position for a duration of 6 months.
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.
SmartyPants Vitamins is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
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