Cosmetics Regulatory Affairs Manager | MoCRA & Compliance

Kelly Services

Indianapolis (IN)

On-site

USD 90,000 - 95,000

Full time

8 days ago
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Benefits offered by this job

Medical insurance
Dental insurance
Vision insurance
Telemedicine
Life insurance
Disability insurance
Retirement plan
Paid holidays
Transit benefit
Paid sick leave

Job summary

Kelly Science & Clinical is seeking a Regulatory Affairs & Compliance Manager in Indianapolis, IN to lead domestic and international regulatory compliance for a cosmetic manufacturer. This onsite 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.

The candidate will oversee adverse event reporting, product registrations, and risk assessments,

Qualifications

  • Bachelor's degree in a relevant field.
  • 3+ years of experience in cosmetic regulatory affairs, compliance, quality, or a related field.
  • 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.

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 external partners.
  • Review ingredients, formulas, labels, packaging, and product information for regulatory compliance (Prop 65 etc).
  • Oversee packaging, recycling, EPR, and related environmental compliance requirements.
  • Respond to regulatory requests 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.
  • Provide factual regulatory guidance to Marketing; advertising review remains with Marketing.

Skills

Regulatory affairs
MoCRA knowledge
FDA cosmetics
Documentation
Project management
English fluency

Education

Bachelor's degree

Tools

Regulatory databases
Microsoft Office

Job description

Kelly Science & Clinical is seeking a Regulatory Affairs & Compliance Manager in Indianapolis, IN to lead domestic and international regulatory compliance for a cosmetic manufacturer. This onsite 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.

The candidate will oversee adverse event reporting, product registrations, and risk assessments,

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