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Job Description
Regulatory Affairs Manager (Cosmetics ONLY) North Caldwell, NJ 07006 Up to $145,000 a year - Full-time Up to $145,000 a year -
Full-time Position Title:
Cosmetics Regulatory Affairs (RA)
Manager Reports To:
Chief Quality and Regulatory Officer Department:
Regulatory Affairs /
Compliance Location:
N. Caldwell, NJ (Full Onsite)
Salary:
$119K-$145K base + full benefits (Med, Dental, Vision, 401k) DOE Company Intro We are a premier global Contract Manufacturing Organization (CMO) and Contract Development and Manufacturing Organization (CDMO) specializing in premium Cosmetics and Over-the-Counter (OTC) skincare. Founded with a vision to bridge the gap between advanced R D and high-volume manufacturing, our organization has become a critical partner for many of the world's most recognizable prestige beauty brands. Executive Summary The Regulatory Affairs (RA) Manager is a pivotal compliance leadership role responsible for navigating, architecting, and executing the organization's global regulatory strategy. This individual serves as the primary technical authority on local and international compliance, ensuring all product formulations, labeling, manufacturing documentation, and raw materials meet the stringent requirements of global governing bodies (FDA, MoCRA, Health Canada, TGA). The RA Manager bridges the gap between R D, Quality, and external clients to ensure seamless, legally compliant product launches and sustained market presence. Leadership & Oversight This role provides direct leadership, strategic guidance, and technical mentorship to the regulatory and compliance functions, including:
Regulatory Compliance Specialists Technical Document Reviewers Labeling and Artwork Compliance Coordinators International Registration Liaisons Core Responsibilities Global Regulatory Leadership:
Ensure 100% organizational compliance with FDA (21 CFR 210/211), MoCRA (Modernization of Cosmetics Regulation Act), Health Canada, TGA/PICS, and international cosmetic/OTC regulations.
Product Registrations & Listings:
Direct and oversee the end-to-end submission process for drug product listings, FDA establishment registrations, and international product dossiers.
Formulation & Ingredient Review:
Partner closely with R D to review raw materials, product formulations, and technical data sheets (TDS/MSDS) to ensure global compliance, regulatory safety limits, and market-specific restriction adherence.
Labeling & Claim Substantiation:
Serve as the final regulatory authority for the review and approval of product packaging artwork, ingredient statements, product claims, and Drug Facts panels to mitigate compliance risks.
Audit & Inspection Defense:
Lead regulatory agency inspections (FDA, EPA, OSHA) and international customer compliance audits. Direct the preparation, technical writing, and timely submission of formal draft responses to regulatory citations or inquiries.
MoCRA Compliance Ownership:
Maintain and execute internal protocols for MoCRA compliance, including mandatory adverse event reporting, facility registration updates, and safety substantiation documentation.
Cross-Functional & Client Liaison:
Act as the primary regulatory point of contact for external premium brand customers, resolving complex regulatory inquiries and facilitating international market expansions. Key Performance Indicators (KPIs)
Submission Accuracy & Speed:
On-time, first-pass approval rate for all regulatory submissions, FDA drug listings, and international product registrations.
Audit Readiness & Defense:
Zero major regulatory observations during agency or customer compliance audits; rapid and robust closure of any open inquiries.
Time-to-Market Efficiency:
Timely execution of formulation and artwork reviews to prevent bottlenecks between R D innovation and mass manufacturing.
Technical Qualifications Regulatory Expertise:
Deep, practical knowledge of
US FDA OTC
drug manufacturing standards, MoCRA regulations, and
ISO 22716
(Cosmetic GMP) guidelines.
International Frameworks:
Proven experience navigating international registration protocols including Health Canada, TGA, and EU cosmetic regulations.
Technical Writing Excellence:
Advanced ability to author standard operating procedures (SOPs), regulatory briefs, safety substantiation dossiers, and formal agency responses.
Data & Specification Analysis:
Exceptionally strong analytical skills to dissect raw material chemical data, limits of detection, and formulation tech sheets.
Requirements Experience:
Minimum of 5+ years of dedicated Regulatory Affairs experience within the Cosmetics, OTC Skincare, or Personal Care manufacturing industry (CMO/CDMO experience is highly preferred).
Education:
Bachelor's degree in Chemistry, Biochemistry, Regulatory Affairs, or a related scientific discipline.
Communication:
Fluent in English reqd.
Systems:
Highly computer literate with experience utilizing regulatory databases, electronic document management systems (e.g., Veeva, TrackWise), and MS Office Suite.
Pay:
Up to $145,000.00 per year
Benefits:
401(k) matching Dental insurance Health insurance Vision insurance
