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Regulatory Affairs Specialist

Job in Melrose Park, Cook County, Illinois, 60161, USA
Listing for: avlon
Full Time position
Listed on 2026-08-09
Job specializations:
  • Pharmaceutical
    Regulatory Compliance Specialist, Healthcare Compliance
Salary/Wage Range or Industry Benchmark: 80000 - 90000 USD Yearly USD 80000.00 90000.00 YEAR
Job Description & How to Apply Below

Position Summary

We are seeking a Regulatory Affairs professional to support and manage regulatory compliance for personal care and hair care products across domestic and international markets. This role is responsible for ensuring products meet all applicable regulations, including U.S. MoCRA requirements and EU/international cosmetic regulations
, and for maintaining compliance throughout the product lifecycle.

The ideal candidate is detail-oriented, proactive, and experienced in global product registrations and regulatory strategy.

Compensation

$80,000.00 - $90,000.00 per year (commensurate with education, skills, and experience)

Key Responsibilities Regulatory Compliance & Strategy
  • Ensure all products comply with U.S. (MoCRA), EU (EC 1223/2009), and other international cosmetic regulations
    .
  • Interpret and apply regulatory requirements to formulations, labeling, and claims.
  • Provide regulatory guidance to R&D, marketing, and operations teams during product development.
Product Registration & Submissions
  • Prepare, review, and submit product registrations and notifications for:
  • EU (CPNP / Responsible Person coordination)
  • U.S. (MoCRA facility registration & product listing)
  • Other international markets as required
  • Maintain and update Product Information Files (PIFs) and technical dossiers.
  • Coordinate with external regulatory consultants and international partners.
MoCRA Compliance (U.S.)
  • Act as or support the Responsible Person for cosmetic products under MoCRA.
  • Manage:
  • Facility registrations
  • Product listings
  • Safety substantiation documentation
  • Adverse event reporting (within required timelines)
  • Maintain compliant documentation systems and support FDA interactions.
International Regulatory Management
  • Lead or support global registration strategies for new product launches.
  • Ensure compliance with EU Responsible Person requirements and global regulatory frameworks
    .
  • Review ingredient listings (INCI), safety data, and labeling for global markets.
Regulatory Intelligence & Industry Monitoring
  • Monitor and communicate changes in regulations, industry standards, and emerging trends impacting personal care products.
  • Assess regulatory impact of formulation or labeling changes.
  • Provide internal training and updates to cross-functional teams.
Cross-Functional Collaboration
  • Partner with R&D, Quality, Manufacturing, and Marketing to ensure compliance across product lifecycle.
  • Support audits, inspections, and regulatory inquiries.
  • Maintain accurate records of all regulatory activities and submissions.
Qualifications Education
  • Bachelor’s degree in Chemistry, Cosmetic Science, Regulatory Affairs, Life Sciences, or related field.
Experience
  • 3–7+ years in cosmetic/personal care regulatory affairs (hair care preferred).
  • Hands-on experience with:
  • EU cosmetic registrations (CPNP / PIFs)
  • MoCRA compliance and FDA requirements
  • Global product registrations across multiple markets
Technical Skills
  • Strong knowledge of:
  • EU Cosmetics Regulation (EC 1223/2009)
  • U.S. FDA / MoCRA requirements
  • Global cosmetic regulatory frameworks
  • Experience preparing regulatory dossiers and submissions.
  • Familiarity with labeling compliance, claims review, and ingredient regulations.
Core Competencies
  • Strong attention to detail and documentation skills
  • Ability to manage multiple projects and deadlines
  • Excellent communication and cross-functional collaboration skills
  • Analytical thinking and problem-solving ability
  • Ability to stay current with evolving regulations and industry changes
Preferred Qualifications
  • Experience in contract manufacturing (CMO/CDMO) or private label environment
  • Knowledge of additional markets (Canada, UK, LATAM, GCC, APAC)
  • Experience with regulatory software or compliance databases
Work Environment
  • Hybrid on-site 3 days in office, 2 days remote (Melrose Park, IL)
  • Occasional interaction with regulatory agencies and external partners
Why This Role Matters

Regulatory Affairs professionals ensure products are safe, compliant, and successfully brought to market globally—serving as the key link between product development and regulatory authorities.

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