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Regulatory Affairs Specialist
Melrose Park, IL
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Melrose Park, IL Job Details Full-time $65,000 - $75,000 a year 1 day ago Benefits Health savings account Health insurance Dental insurance 401(k) Flexible spending account Paid time off Vision insurance 401(k) matching Life insurance Qualifications FDA submissions Teamwork Filing Records management Bachelor's degree Attention to detail Regulatory submission editing and review Full Job Description Position Summary We are seeking a Junior Regulatory Affairs professional to support regulatory compliance for personal care and hair care products across domestic and international markets. The incumbent of 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 knowledgeable in global product registrations and regulatory strategy. Why This Role Matters Regulatory Affairs professionals ensure products are safe, compliant, and successfully brought to market. Serving as the key link between product development and regulatory authorities globally. Key Responsibilities Regulatory Compliance & Strategy Ensure 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 support/guidance to R D, marketing, and operations teams during product development. Product Registration & Submissions Support the preparation, review, and submission of product registrations and notifications for: EU (CPNP / Responsible Person coordination) Product SDSs 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 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 1-2+ 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 or supporting the preparation of 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 On-site or hybrid (Melrose Park, IL) Occasional interaction with regulatory agencies and external partners EU Cosmetics Regulation (EC 1223/2009)
U.S. FDA
/ MoCRA requirements Global cosmetic regulatory frameworks Experience preparing or supporting the preparation of regulatory dossiers and submissions. Familiarity with labeling compliance, claims review, and ingredient regulations.
Pay:
$65,000.00 - $75,000.00 per year
Benefits:
401(k) 401(k) matching Dental insurance Flexible spending account Health insurance Health savings account Life insurance Paid time off Vision insurance Application Question(s): This position is Hybrid - you must be able to come into the office when required.
