Position Summary:

The Regulatory Affairs Specialist is responsible for executing regulatory activities to ensure compliance with U.S. and international regulations governing dietary supplements. This position plays a critical role in developing regulatory strategy, reviewing and approving product documentation, and serving as the regulatory liaison to internal stakeholders, clients, and regulatory authorities.

Location: 737 E 1180 S, American Fork, UT 84003 (On-site)

Schedule: 9 AM - 6 PM

Essential Duties and Responsibilities:

• Conduct regulatory review and approval of product formulations, labels, supplement facts panels, and structure/function claims for domestic and international markets.

• Prepare, review, and maintain regulatory documentation, including product dossiers, master files, certificates of free sale, and ingredient statements.

• Serve as a regulatory subject matter expert (SME) in client meetings, audits, and inspections, providing strategic guidance on formulation compliance, labeling requirements, and market entry pathways.

• Monitor regulatory changes and emerging industry standards; interpret impact and communicate updates to leadership and cross-functional teams.

• Support and advise cross-functional departments, including Quality, R&D, Sales, and Operations, to align regulatory requirements throughout the product lifecycle.

• Manage relationships with certifying bodies and coordinate third-party certifications (e.g., Organic, Non-GMO, NSF, Kosher, Halal).

• Coordinate responses to regulatory inquiries, warning letters, or corrective actions as needed.

• Participate in trade association committees to stay current and knowledgeable of regulations both domestic and international.

Qualifications:

Education and Experience:

• Bachelor’s degree in Regulatory Affairs, Nutrition, Food Science, Chemistry, Biology, or a related discipline (Master’s preferred).

• 3-5 years of regulatory experience in the dietary supplement or food manufacturing industry

• Experience in a contract manufacturing setting strongly preferred.

Knowledge, Skills, and Abilities:

• Deep understanding of current and evolving dietary supplement regulations, including FDA, FTC, Prop 65, and applicable global regulations.

• Strong analytical skills with the ability to interpret complex regulatory texts and apply them practically.

• Proven experience managing complex projects with multiple stakeholders.

• Exceptional attention to detail and organizational skills.

• Excellent written and verbal communication skills.

• Proficiency with regulatory software, databases, and Microsoft Office Suite.

Preferred Certifications:

• Regulatory Affairs Certification (RAC)

• Membership in AHPA, CRN, or related regulatory bodies

Physical Requirements and Work Environment:

• Primarily office-based, with occasional exposure to manufacturing environments.

• Ability to travel occasionally for audits, trade events, or client support.

• May require extended hours to meet regulatory deadlines or respond to audits.