Thorne

Purity-focused nutritional supplements with scientific rigor

Regulatory Affairs Manager

Regulatory & Quality (Life Sciences)Updated on Nov 13

Full-timeSouth Carolina, USA$115k - $125k /yrRemote

About the Job

Requirements

A bachelor's degree in Regulatory Affairs, Life Sciences, Nutrition, Food Science, or a related field is required.
At least 4 years of regulatory affairs experience in the dietary supplement, food, pharmaceutical, or nutraceutical industries is required.
Experience managing domestic U.S. and international regulatory processes, including document preparation and agency interaction, is required.
Strong knowledge of FDA regulations, the Dietary Supplement Health and Education Act, Federal Trade Commission guidelines, current Good Manufacturing Practices, and other relevant domestic standards is required.
The ability to manage regulatory submissions and obtain approvals in multiple global markets is required.
Strong leadership, project management, and organizational skills are required.
Strong verbal and written communication skills, including the ability to translate complex regulations into actionable guidance, are required.
Proficiency in the Microsoft Office Suite is required.

Responsibilities

Ensure compliance with U.S. FDA regulations, including the Dietary Supplement Health and Education Act, Federal Trade Commission advertising standards, and current Good Manufacturing Practices.
Oversee the preparation, submission, and maintenance of regulatory documents, including product labels, claims substantiation, and technical dossiers.
Prepare and process documentation required for product registrations, notifications, and authorizations, and provide technical dossiers as required.
Develop and implement processes to monitor changing regulations globally, interpret their impact on products, and advise leadership.
Collaborate with quality, research and development, and marketing teams to ensure regulatory compliance across product development and marketing initiatives.
Update and maintain Supplement OWL and National Institutes of Health product listings.
Prepare and manage FDA 30-Day Notice Letters.
Serve as the primary liaison between regulatory authorities and the company for domestic matters.
Partner with innovation teams to identify and create opportunities for innovative product claims and positioning, and support innovation development.
Conduct internal training to educate teams on regulatory requirements and standards.
Lead internal audits, support external audits, and ensure corrective actions are implemented.
Assess regulatory risks associated with existing and new markets, advising senior leadership on potential challenges and opportunities.
Identify emerging regulatory changes and potential risks, assess their business impact, and partner with internal teams to prepare for and mitigate upcoming changes.
Participate in trade association activities to support and develop regulatory policies.
Engage with relevant Consumer Healthcare Products Association groups to monitor emerging regulatory developments, assess potential risks, and communicate and support organizational preparedness for upcoming regulatory changes.

Desired Qualifications

Familiarity with international regulatory requirements, including Health Canada, European Food Safety Authority, Association of Southeast Asian Nations, Latin American, and Asia-Pacific markets, is a plus.
Experience with regulatory software systems is a plus.

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.

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 is a plus.
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.

About the Company

Thorne

Purity-focused nutritional supplements with scientific rigor

Thorne is a health and wellness company that makes nutritional supplements. It focuses on purity and scientific backing, testing its products to ensure quality and efficacy for consumers. Its products work by delivering carefully studied nutrients and other ingredients in supplements that people take to support their health. Thorne differentiates itself from competitors through a long history dating back to 1984, a strong emphasis on quality and scientific integrity, and rigorous quality controls. In 2023 the company was acquired by L Catterton, moved off public markets, and continues to pursue growth by expanding research and development. The overall goal is to provide reliable, high-quality supplements that people can trust to support their health and well-being.

Company size: 501-1,000
Company stage: IPO
Headquarters: New York City, United States
Founded: 1984

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