Regulatory Affairs Manager
2 weeks ago
JSHealth Vitamins is seeking a Regulatory Affairs Manager to join our dynamic team in Westwood, Los Angeles. We are a leading science-focused vitamin and wellness brand that provides targeted formulas to help customers meet their personal health goals. Our founder, Jessica Sepel, is a best-selling health author who founded JSHealth Vitamins to provide her community with cutting-edge, research-backed, and targeted vitamin formulas.
We use ingredients at a therapeutic dose to assist with everything from hair health, skin health, gut health, sleep, anxiety, hormones, and more. Ultimately, our mission is to help people achieve the health, beauty, and confidence they deserve, from the inside-out. At JSHealth Vitamins, we are committed to promoting genuine health and well-being. As a renowned brand in the wellness industry, we have consistently offered a range of premium vitamins and supplements that support overall health. We believe that everyone deserves a life of vitality, and our goal is to make this achievable through our products.
As our Regulatory Affairs Manager, you will play a crucial role in our product development team by ensuring that all new and existing products comply with regulatory standards in the United
States. You will be responsible for overseeing the regulatory aspects of our products, from
ingredient review to marketing materials, ensuring they meet the legal and safety standards
required for dietary supplements in the U.S. market.
Key Responsibilities:
- Regulatory Compliance: Ensure all products, including their ingredients and dosages, are in compliance with FDA regulations and other relevant U.S. health and safety standards for dietary supplements.
- Product Development Support: Provide regulatory insights and guidance during the product development process, from concept to market launch, ensuring full compliance with U.S. regulations. Aligning with the manufacturers at all stages of the development phase.
- Label Compliance: Diligently review and approve product labels and packaging to ensure they meet all FDA requirements. This includes accurate ingredient listings, nutritional information, and health claims, ensuring transparency and safety for consumers.
- Marketing Material and Content Compliance: Oversee the review of all marketing materials and content, ensuring they comply with FDA and FTC guidelines. This role requires close collaboration with the marketing team to maintain brand integrity while ensuring regulatory compliance.
- Regulatory Strategy and Planning: Develop regulatory strategies that align with company goals for product launches and market presence, ensuring a smooth path to market for new and reformulated products.
- Documentation and Record-Keeping: Maintain meticulous records of all regulatory documents and submissions, including approvals, correspondence with regulatory agencies, and changes in product formulation or labeling. Manage all documentation from the manufacturers and FDA.
- Manufacturing: Working closely with local manufacturers and Global QA team, being engaged at all phases of the product life cycle as well as being the local interface into the manufacturers.
- Market Surveillance and Regulatory Updates: Stay informed on regulatory changes and industry best practices in the U.S. supplement market. Provide strategic advice to internal teams on navigating regulatory updates and maintaining compliance.
- Stakeholder Engagement: Act as the main point of contact with regulatory authorities and industry associations. Be the main point of contact with relevant authorities on regulatory submissions and enquiries. Offer regulatory support and expertise to internal cross functional teams globally, ensuring a consistent understanding of compliance requirements across the company.
Qualifications:
- Bachelor’s degree in a relevant scientific field (e.g., Biology, Chemistry, Nutrition, Food Science).
- Minimum of 5 years of experience in regulatory affairs, specifically within the dietary supplements or related industries in the U.S. market.
- Deep understanding of FDA regulations and guidelines pertaining to dietary supplements, with specific expertise in label and marketing regulations.
- Experience in engaging with contract manufacturers.
- Experience with the regulatory review of marketing materials and content, including social media and influencer campaigns.
- Proven ability to manage product labeling projects from conception through approval.
- Excellent analytical, communication, and project management skills.
- Detail-oriented with the ability to manage multiple projects in a dynamic, fast-paced environment.
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