Regulatory Manager

Regulatory Manager

The Regulatory Manager is responsible for leading regulatory compliance activities for dietary supplement and cosmetic products throughout the product lifecycle, from concept through commercialization. This role partners with cross functional teams to ensure products meet domestic and international regulatory requirements while supporting product development, manufacturing, labeling, and market readiness. The ideal candidate is an experienced regulatory affairs professional with expertise in FDA regulations, cosmetic compliance, dietary supplement regulations, product labeling, and global regulatory standards.

Responsibilities:

• Lead regulatory strategy and compliance efforts for dietary supplement and cosmetic products from formulation through commercial launch.
• Evaluate ingredient legality, dosage limits, and product formulations to ensure compliance with applicable domestic and international regulations.
• Review and approve product labels, Supplement Facts panels, ingredient declarations, INCI listings, warning statements, and marketing claims for regulatory accuracy.
• Ensure compliance with FDA, FTC, cGMP, MoCRA, California Proposition 65, and other applicable regulatory requirements.
• Monitor evolving regulatory requirements and implement updates to internal policies, procedures, and compliance programs.
• Oversee the preparation, review, and maintenance of regulatory documentation, including ingredient specifications, product specifications, Certificates of Analysis, New Dietary Ingredient assessments, Product Information Files, and technical documentation.
• Collaborate closely with Research and Development, Quality Assurance, Supply Chain, Purchasing, Operations, and Commercial teams to identify and resolve regulatory issues early in the product development process.
• Provide regulatory guidance during product innovation, formulation development, and commercialization activities to support efficient product launches.
• Support internal and external audits, regulatory inspections, customer inquiries, and certification activities by providing regulatory expertise and documentation.
• Assess regulatory risks and recommend practical compliance solutions that support business objectives while maintaining product safety and regulatory integrity.

Qualifications:

• Bachelor's degree in Regulatory Affairs, Food Science, Chemistry, Biology, Pharmaceutical Sciences, Cosmetic Science, Nutrition, or a related scientific discipline.
• Minimum of 6 years of progressive regulatory affairs experience within dietary supplements, cosmetics, consumer products, pharmaceuticals, food manufacturing, or another highly regulated industry.
• Minimum of 2 years of leadership, supervisory, or regulatory project management experience.
• Strong knowledge of FDA regulations, 21 CFR Part 101, 21 CFR Part 111, MoCRA, FTC advertising requirements, California Proposition 65, and cosmetic labeling regulations.
• Experience reviewing dietary supplement and cosmetic labeling, ingredient compliance, structure function claims, health claims, and product marketing materials.
• Comprehensive understanding of domestic and international regulatory requirements, including Health Canada, FSANZ, cosmetic regulations, and global compliance standards.
• Experience preparing and maintaining regulatory documentation, technical files, Certificates of Analysis, ingredient specifications, and compliance records.
• Excellent project management, analytical thinking, organizational, and problem solving skills.
• Strong written and verbal communication skills with the ability to explain complex regulatory requirements to technical and non technical stakeholders.
• Proficiency with Microsoft Office, ERP systems, regulatory databases, document management systems, and business software.

Desired Qualifications:

• Regulatory Affairs Certification or other relevant professional certification.
• Experience supporting private label, contract manufacturing, or consumer packaged goods environments.
• Knowledge of international product registration, import and export compliance, and global market access requirements.
• Experience working with quality management systems, supplier qualification programs, and regulatory audits.
• Familiarity with product lifecycle management systems, compliance software, and AI enabled regulatory tools.
• Demonstrated ability to lead cross functional regulatory initiatives while supporting innovation, operational excellence, and continuous process improvement.