About this role
At Thorne, we work to deliver high-quality, science-backed solutions to empower individuals to take a proactive approach to their well-being. Each day begins with a mission to help others discover and achieve their best health. We count on our team members to challenge and push the boundaries to make that happen. At Thorne, you’ll be joining a team of more than 750 passionate individuals committed to our cause of providing superior health solutions at every age and life stage. The Regulatory Affairs Manager will be responsible for managing and overseeing all regulatory activities to ensure compliance with domestic and international regulatory requirements for dietary supplements and other regulated products. This role will lead cross-functional efforts to bring new products to market, maintain compliance for existing products, and navigate complex global regulations to support business growth. The Manager will possess a strong understanding of dietary supplement regulations, including FDA (U.S.), Health Canada, EFSA (Europe), and other international authorities, with a proven track record of successfully managing global product portfolios. Regulatory Compliance Ensures compliance with U.S. FDA regulations, including DSHEA (Dietary Supplement Health and Education Act), FTC advertising standards, and cGMPs. Oversees the preparation, submission, and maintenance of regulatory documents, including product labels, claims substantiation, and technical dossiers. Prepares and processes documentation required for product registrations, notifications, and authorizations and to provide technical dossiers as required. Develops and implements processes to monitor changing regulations globally, interpreting their impact on products and advising leadership. Collaborates with quality, R&D, and marketing teams to ensure regulatory compliance across all product development and marketing initiatives. Updates and maintains Supplement OWL and NIH product listings. Prepares and manages FDA 30-Day Notice Letters. Cross-Functional Leadership Serves as the primary liaison between regulatory authorities and the company for domestic matters. Partners with innovation teams to proactively identify and create opportunities for innovative product claims, positioning, and to support the development of innovation. Conducts internal training to educate teams on regulatory requirements and standards. Leads internal audits, supports external audits, and ensures corrective actions are implemented. Risk Management and Strategy Assesses regulatory risks associated with existing and new markets, advising senior leadership on potential challenges and opportunities. Proactively identifies emerging regulatory changes and potential risks, assesses their business impact, and partners with internal teams to prepare for and mitigate upcoming changes. Is involved in Trade Association activities to support and develop regulatory policies. Engages with relevant Consumer Healthcare Products Association (CHPA) groups to monitor emerging regulatory developments, assess potential risks, and proactively communicate and support organizational preparedness for upcoming regulatory changes.