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Thorne is seeking a Regulatory Affairs Manager to lead all regulatory activities ensuring compliance with domestic and international requirements for dietary supplements and regulated health products. This role manages cross-functional efforts to bring new products to market, maintain compliance for existing products, and navigate complex global regulations supporting business growth.
Key responsibilities include:
Regulatory Compliance: Ensure compliance with U.S. FDA regulations including DSHEA, FTC advertising standards, and cGMPs. Oversee preparation, submission, and maintenance of regulatory documents including product labels, claims substantiation, and technical dossiers. Manage international regulatory submissions and approvals across Health Canada, EU, and APAC markets. Process documentation for product registrations, notifications, and authorizations. Manage state licensing requirements for medical device storage and distribution where applicable. Develop and implement processes to monitor changing global regulations and advise leadership on impacts. Collaborate with quality, R&D, and marketing teams on regulatory compliance. Maintain Supplement OWL and NIH product listings. Prepare and manage FDA 30-Day Notice Letters.
Cross-Functional Leadership: Serve as primary liaison between regulatory authorities and the company domestically and internationally. Partner with innovation teams to identify opportunities for innovative product claims and positioning. Conduct internal training on regulatory requirements and standards. Lead internal audits, support external audits, and ensure corrective actions are implemented.
Risk Management: Assess regulatory risks for existing and new markets, advising senior leadership on challenges and opportunities. Participate in trade association activities to support regulatory policy development.
Required qualifications: Bachelor's degree in Regulatory Affairs, Life Sciences, Nutrition, Food Science, or related field. Minimum 4+ years regulatory affairs experience in dietary supplements, food, pharmaceutical, or nutraceutical industries. Experience managing domestic and international regulatory processes including document preparation and agency interaction. Strong knowledge of FDA regulations, DSHEA, FTC guidelines, cGMPs. Familiarity with international requirements including Health Canada, EFSA, ASEAN, LATAM, and APAC markets. Proven ability to manage regulatory submissions and obtain approvals in multiple global markets. Excellent leadership, project management, and organizational skills. Strong verbal and written communication abilities. Proficiency in MS Office Suite; regulatory software experience a plus.
