Regulatory Affairs Manager

Description

RESPONSIBILITIES

• 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.

• 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. 

• 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. 

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 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. 

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