REGULATORY AFFAIRS MANAGER- Remote Opportunity!

At Thorne we make products that matter - ones that make people's lives better. 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.

POSITION SUMMARY: 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 – Satisfactorily performing and/or achieving the following Responsibilities are essential duties of the job. 

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.

Cross-Functional Leadership 

• Serves as the primary liaison between regulatory authorities and the company for domestic and international matters.
• 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.

 What You Need: 

EXPERIENCE / COMPETENCIES / PROFICIENCIES – Satisfactorily achieving and/or meeting the following Experience, Competencies, and Proficiencies are essential duties of the job: 

•  Experience and/or Education: By training, education and/or experience, employee must be able to perform the essential duties of the job. Bachelor’s degree in Regulatory Affairs, Life Sciences, Nutrition, Food Science, or related field. Minimum 5-7 years of experience in regulatory affairs, preferably 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:

At Thorne, we offer employees the chance to work with great people on exciting projects, with opportunity for growth. We also provide a full range of benefits for you and your eligible family members, such as:

• Competitive compensation
• 100% company-paid medical, dental, and vision insurance coverage
• 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
• A safe and clean work environment

A little bit more about us. 

Thorne is the leader in science-backed health and wellness solutions committed to helping individuals live healthier longer.  As the top recommended clinical brand by healthcare practitioners, Thorne offers a comprehensive range of products including nutritional supplements and health tests designed to meet the unique needs of individuals at every stage of life. Founded in 1984, Thorne products are formulated with the highest-quality ingredients, supported by clinical research, and rigorously tested to ensure purity, potency, and efficacy. Thorne is the only supplement manufacturer that collaborates with Mayo Clinic on health and wellness research and content and is trusted by 47,000+ health-care professionals, thousands of professional athletes, more than 100 professional sports teams, multiple U.S. National Teams, and more than five million consumers. For more information, visit Thorne.com

If you want to make a difference in the lives of others consider becoming part of the Thorne team.