Regulatory Affairs Associate

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 MedTech 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 senior Toxicologist to join our dynamic team at RegTrac. In this pivotal role, you will leverage your expertise in toxicology to guide the development of safe and effective products, ensuring compliance with regulatory standards while championing innovative research initiatives. You'll play a critical role in shaping our product safety strategy and influencing cross-functional teams to integrate toxicological insights into the overall product development lifecycle.

Key Responsibilities:

·       Conduct toxicological safety assessments for cosmetic and consumer products in compliance with regulatory standards.

·       Review and evaluate qualitative and quantitative formulations and supporting raw material documentation.

·       Analyze data from stability studies, microbial testing, challenge tests, SPF evaluations, and related safety studies.

·       Prepare and author Cosmetic Product Safety Reports (CPSRs), PIF and other toxicology & cosmetic related regulatory documentation.

·       Interpret toxicological profiles of ingredients and identify potential risks or concerns.

·       Ensure compliance with relevant regulatory frameworks, including EU Regulation 1223/2009, MoCRA regulations and international equivalents.

·       Stay updated with current toxicology research, regulatory changes, and ingredient safety guidelines.

·       Provide expert input on safety thresholds, exposure assessments, and formulation recommendations.

Qualifications:

·      A university degree or higher qualification in toxicology, pharmacy, medicine, biochemistry, or a related discipline, in accordance with EU Regulation 1223/2009 and USFDA regulations

·      Extensive knowledge of toxicological testing methods and regulatory guidelines

· years of experience in cosmetic regulatory and toxicology

·      Proven track record of developing and executing toxicological studies for new product development

·      Strong analytical and problem-solving skills, with the ability to interpret complex data and communicate findings effectively to stakeholders

·      Have excellent written and oral communications skills to communicate clearly and effectively with third parties, regulatory authorities and management

·      Inquisitive, self-motivated and focused

Why Join RegTrac?

At
RegTrac

, you'll join a collaborative, supportive team that values expertise, curiosity, and purpose. The company fosters a culture of continuous learning, where your voice matters and your growth is actively supported through mentorship, diverse global projects, and real responsibility. You'll be part of a close-knit community passionate about regulatory science and improving healthcare outcomes, with the flexibility to work remotely and balance life outside of work. At RegTrac, it's not just about compliance—it's about making a meaningful impact together, in a place where people genuinely enjoy what they do and who they do it with.