Regulatory Affairs & Compliance Manager

Regulatory Affairs & Compliance Manager

Kelly Science & Clinical is seeking a Regulatory Affairs & Compliance Manager to lead domestic and international regulatory compliance for a cosmetic manufacturer in Indianapolis. This role serves as the primary regulatory resource for internal teams, customers, distributors, regulatory authorities, and external partners while supporting business growth and minimizing regulatory risk.

Key Responsibilities

• Lead the day-to-day Regulatory Affairs & Compliance function, including systems, records, procedures, deadlines, and assigned staff.
• Ensure compliance with FDA cosmetic requirements and MoCRA, including facility registrations, product listings, renewals, and updates.
• Manage the company's adverse event reporting program, including assessment, investigation, documentation, reportability determinations, and FDA submissions.
• Conduct consumer and product regulatory risk assessments and coordinate corrective actions as needed.
• Manage domestic and international product registrations, including country-specific ingredient, labeling, notification, and responsible-person requirements.
• Serve as the primary regulatory contact for Biorius and other external regulatory partners.
• Review ingredients, formulas, labels, packaging, and product information for regulatory compliance, including Proposition 65 and applicable international requirements.
• Oversee packaging, recycling, extended producer responsibility (EPR), and related environmental compliance requirements.
• Respond to regulatory requests from customers, retailers, distributors, and internal teams and maintain accurate product and compliance information.
• Maintain regulatory databases, registrations, approvals, certifications, documentation, and renewal calendars.
• Provide regulatory training and guidance to employees and cross-functional teams.
• Support inspections, audits, agency inquiries, and cross-functional initiatives related to compliance and market expansion.
• Provide factual regulatory guidance to Marketing when requested; advertising and promotional review remains with Marketing.

Required Qualifications

• Bachelor's degree in a relevant field.
• 3+ years of experience in cosmetic regulatory affairs, compliance, quality, or a related field preferred.
• Strong knowledge of FDA cosmetic regulations, MoCRA, adverse event reporting, and consumer risk assessment.
• Working knowledge of Proposition 65, ingredient restrictions, and chemical compliance.
• Strong organizational, analytical, documentation, and project management skills.
• Excellent written and verbal communication skills and attention to detail.
• Ability to manage multiple priorities and deadlines in a fast-paced environment.
• Proficiency with Microsoft Office and regulatory/product information databases.
• Fluent in written and spoken English.

Preferred Qualifications

• Experience with international cosmetic regulations and market access.
• Knowledge of cosmetic labeling, packaging, recycling, and EPR requirements.
• Experience working with Biorius or similar external regulatory partners.