Regulary Affairs Specialist

Description

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

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.