Regulatory Affairs Associate - Cosmetics

Regulatory Affairs Associate – Cosmetics

Company Overview

RegTrac is a leading healthcare regulatory partner specializing in Global Regulatory Affairs, Quality Systems, and Compliance for Medical Devices, Cosmetics, and Consumer Products. With expertise in navigating regulatory requirements across diverse markets, RegTrac empowers companies to innovate and expand globally while ensuring regulatory compliance. Our comprehensive services include strategic insights, compliance mastery, and training programs in Regulatory Affairs to support businesses in achieving success.

Role Description

We are seeking a highly skilled and experienced Toxicologist specializing in Cosmetics to join our dynamic team at RegTrac. In this pivotal role, you will leverage your expertise in cosmetic product safety to guide the development of compliant, high-quality formulations. You will be responsible for ensuring that all cosmetic products meet regulatory requirements and safety standards while contributing to innovative research and product development initiatives.

Key Responsibilities

• Conduct toxicological safety assessments for cosmetic products in compliance with EU Regulation 1223/2009, US MoCRA, CDSCO regulations, and other international frameworks.
• Review and evaluate qualitative and quantitative formulations and supporting raw material documentation.
• Analyze data from stability studies, microbial testing, preservative efficacy (challenge) tests, SPF evaluations, and other cosmetic safety studies.
• Prepare and author Cosmetic Product Safety Reports (CPSRs), Product Information Files (PIFs), and other toxicology-related cosmetic documentation.
• Interpret toxicological profiles of cosmetic ingredients and identify potential risks or safety concerns.
• Provide expert input on safety thresholds, exposure assessments, and formulation recommendations for cosmetics.
• Stay updated with current cosmetic toxicology research, regulatory changes, and ingredient safety guidelines across EU, US, and Indian (CDSCO) markets.
• Collaborate with cross-functional teams (R&D, QA, Regulatory Affairs) to integrate toxicological insights into product development.

Qualifications

• A university degree or higher qualification in toxicology, pharmacy, medicine, biochemistry, or a related discipline, in accordance with EU Regulation 1223/2009, MoCRA, and CDSCO requirements.
• In-depth knowledge of toxicological testing methods, cosmetic ingredient safety, and regulatory frameworks (EU, US, CDSCO, and international equivalents).
• 2+ years of experience in cosmetic regulatory toxicology.
• Proven experience in preparing CPSRs and PIFs for cosmetic products.
• Strong analytical and problem-solving skills, with the ability to interpret complex toxicology data and communicate findings effectively.
• Excellent written and oral communication skills to interact with third parties, regulatory authorities, and internal teams.
• Self-motivated, detail-oriented, and driven by curiosity.

Why Join RegTrac?