Regulatory Manager
On-siteAkron, Ohio, United States
Job Summary
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 adherence to FDA, FTC, cGMP, MoCRA, and international standards. Review and approve product labels, Supplement Facts panels, ingredient declarations, INCI listings, warning statements, and marketing claims for regulatory accuracy. Oversee preparation and maintenance of regulatory documentation, including ingredient specifications, Certificates of Analysis, and Product Information Files. Collaborate with R&D, Quality Assurance, Supply Chain, and Commercial teams to identify and resolve regulatory issues early. Provide regulatory guidance during product innovation and support internal and external audits, inspections, and certification activities. Assess regulatory risks and recommend practical compliance solutions that support business objectives while maintaining product safety and integrity.
Required 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.
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