Regulatory Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Perform regulatory assessments of product labels, packaging, marketing materials, websites, social media content, and advertising assertions.

• Assess claim validation and provide regulatory advice to ensure adherence to FDA, FTC, and relevant industry standards.

• Examine formulas, ingredient specifications, standard operating procedures (SOPs), quality documentation, and compliance programs.

• Assist in regulatory strategies, product development efforts, and due diligence tasks for clients.

• Draft and evaluate regulatory reports, compliance evaluations, and associated documentation.

• Act as a subject matter expert on food and dietary supplement regulations and upcoming industry requirements.

• Collaborate with executive leadership to foster the growth and advancement of the MRS department and future team members.

⛳️ Requirements

• Over 12 years of experience in Regulatory Affairs, Quality, Compliance, or a related field within the food, dietary supplement, or closely associated industries.

• More than 8 years of direct experience in reviewing and approving food and dietary supplement labeling and claims.

• In-depth knowledge of FDA food labeling regulations, particularly 21 CFR Part 101.

• Capability to confidently interpret and implement regulatory requirements.

• Strong comprehension of claim validation, compliance evaluations, and regulatory risk assessment.

• Exceptional written and verbal communication skills.

• Ability to convey complex regulatory concepts to clients and internal stakeholders effectively.

• Experience in managing projects, client relationships, and cross-functional initiatives.

• Preferably possess USDA labeling experience.

• Proficiency in Spanish is a plus.

• Previous consulting experience supporting various clients and product categories is preferred.

• Experience in leading, mentoring, or developing regulatory teams is preferred.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Flexible work hours and remote work options.

• Professional development opportunities, including training and certification programs.

• Supportive and collaborative work environment.