Regulatory Affairs Specialist - Cosmetics & Homecare (Homebased)

Outsourced Quality Assured Services Pty; United States; Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Homebased work

Job summary

Outsourced Quality Assured Services Pty in the United States is seeking a Regulatory Affairs Specialist - Cosmetics & Homecare (Homebased) to own technical regulatory reviews and ensure products meet U.S. regulatory requirements while supporting international market activities.

You will review formulations, labeling, and claims, prepare regulatory documentation, and collaborate with internal teams, clients, and suppliers to resolve issues and support product launches.

Qualifications

• 3+ years of Regulatory Affairs experience in U.S. cosmetics/homecare.
• Hands-on experience reviewing formulations, labeling and claims.
• Knowledge of FDA labeling, MoCRA and FTC advertising.

Responsibilities

• Independently review product formulations, labeling and claims for U.S. compliance.
• Prepare regulatory assessments with references and action items.
• Collaborate with R&D, QA and clients to resolve issues.
• Monitor regulatory changes and update product dossiers.

Skills

Regulatory Affairs

FDA MoCRA

U.S. cosmetics regulatory

Regulatory documentation

Regulatory submissions

Job description

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Regulatory Affairs Specialist - Cosmetics & Homecare (Homebased)

Full Time Employee

Job Summary

echnical regulatory reviews, ensuring products meet applicable U.S. regulatory requirements while supporting compliance activities for selected intern

Job Description

In this role, you will take ownership of technical regulatory reviews, ensuring products meet applicable U.S. regulatory requirements while supporting compliance activities for selected international markets.
Working closely with Regulatory leadership, you will review product formulations, ingredients, labeling, claims, and technical documentation to identify compliance gaps and recommend practical solutions. You will also collaborate with internal teams, clients, and suppliers to resolve regulatory concerns and support successful product launches.
The ideal candidate has hands-on experience in both U.S. cosmetics and homecare regulatory affairs, strong technical knowledge, and the ability to independently manage projects, communicate clear recommendations, and deliver accurate regulatory assessments with minimal day-to-day supervision.

Key Responsibilities1. Regulatory Compliance & Technical Reviews

• Independently review product formulations, ingredients, packaging, labeling, marketing claims, and online content to ensure compliance with applicable U.S. regulations.
• Assess product classifications and identify potential regulatory risks, compliance gaps, and documentation requirements.
• Provide clear, documented regulatory assessments, including applicable regulatory references, recommended corrective actions, and approval status.
• Review ingredient concentrations, perform finished-product calculations, and verify the accuracy and consistency of technical information.

2. Product Documentation & Ingredient Assessments

• Prepare, review, and maintain product dossiers, Quantitative Ingredient Lists (QILs), INCI ingredient declarations, supplier declarations, and supporting compliance documentation.
• Reconcile product formulas against raw material compositions, fragrance allergen reports, IFRA certificates, and Safety Data Sheets (SDSs).
• Identify missing, inconsistent, or conflicting technical information and coordinate with suppliers and relevant teams to obtain accurate documentation.
• Maintain complete, accurate, and controlled regulatory records and review histories.

3. U.S. Cosmetics & Homecare Regulatory Requirements

• Support FDA and MoCRA compliance activities, including facility registration, product listing, safety substantiation records, and applicable regulatory submissions in coordination with the authorized responsible party.
• Evaluate cosmetic labeling, product claims, and marketing materials against applicable FDA and FTC requirements.
• Assess homecare products for California SB 258 ingredient disclosure requirements, CARB consumer product category and VOC requirements, and applicable hazard labeling and warning requirements.
• Identify potential drug or pesticidal claims and elevate products or claims requiring additional regulatory assessment before approval.
• Monitor and elevate potential reportable adverse events in accordance with applicable requirements.

4. International Regulatory Support

• Support regulatory documentation, product dossiers, registrations, and notifications for assigned international markets.
• Coordinate with EU/UK Responsible Persons and qualified safety assessors to support applicable product compliance requirements.
• Identify market-specific documentation gaps and coordinate the collection of required information and supporting records.
• Track applicable submission requirements, documentation updates, and regulatory deadlines.

5. Product Claims & Supporting Evidence

• Review product claims against available testing and supporting evidence, including HRIPT, preservative efficacy, stability, compatibility, and performance studies.
• Assess whether available evidence adequately supports proposed claims and identify limitations or additional documentation requirements.
• Recommend appropriate claim wording, additional testing, or specialist safety and toxicology review when necessary.
• Document findings and communicate recommendations to relevant stakeholders.

6. Regulatory Monitoring & Project Management

• Monitor relevant regulatory changes and assess their potential impact on existing and upcoming products.
• Recommend necessary formula, labeling, testing, and documentation updates, and maintain action plans to address compliance gaps.
• Manage assigned regulatory projects from initial review through resolution and completion, ensuring deadlines and priorities are met.
• Prepare regulatory responses to client, internal, and regulatory authority inquiries for approval as required.
• Complete routine technical reviews independently within delegated authority and elevate high-risk, uncertain, or out-of-scope decisions to Regulatory leadership.

7. Cross-Functional & Client Collaboration

• Partner with R&D, Quality, Manufacturing, Product Development, and client teams to resolve regulatory issues and support product launches.
• Communicate regulatory findings, recommendations, and requirements clearly to clients, suppliers, and internal stakeholders.
• Follow up on outstanding documentation, technical questions, and corrective actions to ensure timely resolution.
• Maintain professional, responsive, and solution-oriented communication throughout the regulatory review process.

Qualifications & Requirements

• At least 3 years of relevant Regulatory Affairs experience, with 5+ years preferred.
• Demonstrated hands-on regulatory experience in U.S. cosmetics and personal care products, including direct homecare regulatory experience. Both are required.
• Proven ability to independently review product formulations, ingredient compositions, packaging, artwork, claims, and technical documentation.
• Experience interpreting regulatory requirements, performing finished-product concentration calculations, identifying compliance gaps, and preparing documented regulatory recommendations.
• Working knowledge of FDA cosmetic labeling requirements, MoCRA, and FTC advertising and claims principles.
• Familiarity with California SB 258, CARB consumer product regulations, VOC requirements, and applicable homecare hazard labeling requirements.
• Strong technical writing, verbal communication, and analytical skills, with excellent attention to detail.
• Ability to manage multiple projects, priorities, and deadlines with minimal day-to-day supervision.
• Comfortable communicating directly with clients, suppliers, and cross-functional teams.
• Availability to work with agreed-upon overlap with Product Society's working hours.

Preferred Qualifications

• Experience using Good Face or comparable formulation, product compliance, or regulatory management software.
• Experience working with contract manufacturers and product development teams.
• Knowledge of fragrance composition, fragrance allergen assessments, IFRA requirements, and supporting technical documentation.
• Experience preparing EU/UK product dossiers, coordinating product notifications, and working with Responsible Persons and qualified safety assessors.
• Experience supporting regulatory compliance across multiple product categories or international markets.

Additional Information

• M to F, 6pm to 3am PH Time
• Homebased