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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 motivated Regulatory Affairs Associate – Cosmetics to support regulatory consulting projects for clients across the cosmetics industry. The successful candidate will be responsible for managing cosmetic registration and compliance activities, preparing regulatory submissions, providing regulatory guidance to clients, and ensuring adherence to applicable cosmetic regulations. This role offers an excellent opportunity to work on diverse regulatory projects while building expertise in cosmetic regulations and market access strategies.
Key Responsibilities:
· Manage and support cosmetic regulatory projects for global cosmetic manaufacturers.
• Prepare, review, and submit cosmetic registration applications and supporting documentation to CDSCO, EU, UK Cosmetic registrations and other applicable regulatory authorities.
• Provide regulatory guidance to clients regarding product registrations, compliance requirements, labeling, claims substantiation, and market entry strategies.
• Review product formulations, ingredient declarations, labels, packaging artwork, and marketing claims for regulatory compliance.
• Preparation of PIF (Product Information File), CPSR (Cosmetic Product Safety Report), specifications and registration documents.
• Monitor and interpret changes in cosmetic regulations, standards, and guidance documents, providing timely updates and recommendations to clients and internal teams.
• Support clients in responding to regulatory authority queries, deficiency letters, and compliance-related communications.
• Collaborate with cross-functional teams, manufacturers, testing laboratories, and regulatory authorities to facilitate successful project execution.
• Support business development activities by providing regulatory input for client proposals and new service offerings.
• Contribute to the development of internal regulatory procedures, templates, and best practices.
Skills & Experiences
· 2 to 3 years of experiences in Regulatory Affairs within the cosmetics industry or a regulatory consulting environment including hands-on experience with CDSCO cosmetic registrations and Indian cosmetic regulatory requirements.
· Strong understanding of the Cosmetics Rules, 2020 and EU Cosmetic regulation labeling requirements, ingredient compliance, and cosmetic product registration processes.
· Excellent written and verbal communication skills with the ability to interact professionally with clients, regulatory authorities, and internal stakeholders.
· Strong analytical, problem-solving, and project management skills.
· Attention to detail, self-motivated, proactive, and capable of working independently as well as within a collaborative team environment.
· Proficiency in Microsoft Office applications and document management systems.
Qualifications:
· Master's degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, Cosmetic Science, or a related field.
· 2–5 years of experience in Cosmetic Regulatory Affairs
· Experience in client-facing regulatory projects and regulatory submissions to CDSCO is preferred.
· Exposure to international cosmetic regulations and market access requirements would be an added advantage.
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.
Job ID: 149078885
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