Job Description
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.
RESPONSIBILITIES
Regulatory Compliance – Domestic & International
- 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.
- Manages international regulatory submissions and approvals (e.g., Health Canada NHPs, EU notifications, APAC market approvals, etc.).
- Prepares and processes documentation required for product registrations, notifications, and authorizations and to provide technical dossiers as required.
- Manages and maintains state licensing requirements for the storage and distribution of medical devices, where applicable.
- 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 and international 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.
- Is involved in Trade Association activities to support and develop regulatory policies.
WHAT YOU NEED
- Bachelor’s degree in Regulatory Affairs, Life Sciences, Nutrition, Food Science, or related field.
- Minimum 4+ years of experience in regulatory affairs, within the dietary supplement, food, pharmaceutical, or nutraceutical industries.
- Experience managing domestic (U.S.) and international regulatory processes, including document preparation and agency interaction.
- Strong knowledge of FDA regulations, DSHEA, FTC guidelines, cGMPs, and other relevant domestic standards.
- Familiarity with international regulatory 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 skills, with the ability to translate complex regulations into actionable guidance.
- Proficient in MS Office Suite; experience with regulatory software systems is a plus.
WHAT WE OFFER
- Competitive compensation
- 100% company-paid medical, dental, and vision insurance coverage for employees
- Company-paid short- and long-term disability insurance
- Company- paid life insurance
- 401k plan with employer matching contributions up to 4%
- Gym membership reimbursement
- Monthly allowance of Thorne supplements
- Paid time off, volunteer time off and holiday leave
- Training, professional development, and career growth opportunities
Originally posted on Himalayas
