Demo

Senior Regulatory Affairs Specialist

All About Personnel
Village, IL Full Time
POSTED ON 11/19/2025
AVAILABLE BEFORE 1/19/2026
Regulatory Affairs SpecialistPosition SummaryThe Regulatory Affairs Specialist ensures global compliance of all cosmetic and OTC (Over-the-Counter) products with applicable regulatory requirements. This position supports and manages regulatory activities across product development, manufacturing, labeling, and market expansion. Working cross-functionally with R&D, Quality, Marketing, and Operations, the Specialist maintains the regulatory integrity of new and existing products while proactively monitoring evolving regulations in the U.S., Canada, EU, and other key markets.This role helps establish and implement the processes, systems, and documentation necessary to maintain a compliant and robust global regulatory framework.Key ResponsibilitiesRegulatory Documentation & Product CompliancePrepare and maintain INCI ingredient lists, quantitative formulas, Component Composition Summaries (CCS), Safety Data Sheets (SDS), and claims substantiation packages.Ensure all technical documentation, product registrations, and label claims are accurate and compliant with global regulatory frameworks.Manage and maintain regulatory databases, dossiers, and master files to support audits and inspections.Labeling & Claims ReviewReview product labeling, artwork, and marketing materials for compliance with FDA, MoCRA, Health Canada, EU Cosmetics Regulation (EC) No 1223/2009, and state-level requirements such as California Proposition 65.Partner with Marketing and Legal to ensure that all consumer-facing communications meet substantiation and compliance standards.Regulatory Submissions & Market ExpansionSupport or manage product listings and facility registrations under FDA MoCRA.Prepare and submit EU CPNP/SCPN notifications, safety assessments, and global market dossiers as required.Coordinate with international partners to ensure timely completion of product registrations and renewals.Regulatory Intelligence & TrainingMonitor, interpret, and communicate changes in global regulatory requirements affecting product composition, labeling, and claims.Update R&D formulation guidelines and internal SOPs to reflect current regulations.Deliver regulatory training and guidance to cross-functional teams as appropriate.Cross-Functional CollaborationProvide regulatory input during New Product Development (NPD) to ensure early-stage compliance.Work closely with R&D and Quality on raw material reviews, supplier documentation, and formulation change control.Participate in audits, legal inquiries, and product defense initiatives as needed.QualificationsBachelor’s degree in Chemistry, Biology, Regulatory Science, or related scientific discipline.2–4 years of experience in Regulatory Affairs for cosmetics, OTC, or related personal-care categories.Strong working knowledge of FDA, MoCRA, Health Canada, EU Cosmetics, and state-specific regulations.Experience in SDS authoring, label and claims review, and global product registration.Understanding of Good Manufacturing Practices (cGMPs) and quality documentation.Familiarity with NGO and retailer compliance frameworks (e.g., Non-GMO Project, Target Clean, Ulta Clean).Proficiency in Microsoft Office (Word, Excel, PowerPoint, Access); experience with regulatory systems (WERCS, Veeva Vault, SAP EHS, or equivalent) preferred.Strong analytical, organizational, and written communication skills.Ability to interpret regulations, resolve complex compliance questions, and collaborate effectively across teams.Core CompetenciesRegulatory Insight: Deep understanding of product classification and global regulatory frameworks.Attention to Detail: Ensures accuracy and consistency in documentation and submissions.Cross-Functional Communication: Translates regulatory requirements into actionable guidance for R&D and Marketing teams.Problem Solving: Identifies potential compliance risks and develops timely solutions.Adaptability: Keeps pace with evolving legislation and regulatory expectations.Performance IndicatorsTimely and accurate completion of product registrations and listings.Zero compliance-related product holds or audit findings.Up-to-date regulatory documentation and training for all assigned product lines.Consistent support of new product launches within designated timelines. Company DescriptionAll About Personnel was founded with the goal of providing high quality management consulting, and staffing services to small, medium, and large sized companies. Our primary objective in our consulting and staffing engagement is to improve our client’s profitability by increasing productivity, improving quality and competitiveness and reducing turnover by finding the right talent in your industry. During the past twenty years, staffing along with the talent has changed significantly and it is our goal to assist our clients by helping them improve their profitability by increasing their efficiency rate and reducing turnover. Our client scope is leading companies in consumer manufacturing, food manufacturing, wholesale, distribution, transportation, government, and commercial printing.

Salary : $20 - $25

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