Remote Global Regulatory Affairs Manager

Thorne; South Carolina; Hybrid; USD 115,000 - 125,000; Full time

Benefits offered by this job

100% company-paid medical, dental, and

401k plan with employer matching up to

Job summary

Thorne, a leader in science-backed health solutions, seeks a Regulatory Affairs Manager to oversee regulatory activities for dietary supplements and other products. You will guide domestic and international submissions, ensure compliance, and support new product introductions.

Ideal candidates have 4+ years in regulatory roles, strong FDA knowledge, and experience navigating Health Canada, EFSA, and APAC markets, with excellent leadership and communication skills.

Qualifications

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Nutrition, Food Science, or related field.
• Minimum 4+ years of experience in regulatory affairs, within dietary supplements, 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.

Responsibilities

• Ensures compliance with U.S. FDA regulations, including DSHEA, FTC advertising standards, and cGMPs.
• Oversees 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).
• Prepares and processes documentation required for product registrations, notifications, and authorizations; provides technical dossiers as required.
• Manages and maintains state licensing requirements for 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.

Skills

Leadership

Project management

Regulatory knowledge

Communication

Organizational skills

Education

Bachelor's degree in Regulatory Affairs

Tools

MS Office Suite

Regulatory software

Job description

Thorne, a leader in science-backed health solutions, seeks a Regulatory Affairs Manager to oversee regulatory activities for dietary supplements and other products. You will guide domestic and international submissions, ensure compliance, and support new product introductions.

Ideal candidates have 4+ years in regulatory roles, strong FDA knowledge, and experience navigating Health Canada, EFSA, and APAC markets, with excellent leadership and communication skills.