Bilingual Korean/English Senior Regulatory Affairs Manager - Cosmetics, OTC & Supplements (FDA [...]

Job Summary Our client is a leading lifestyle and beauty company dedicated to helping customers achieve their personal and aesthetic aspirations. Guided by the core values of Beautiful, Healthy, and Refreshing, they innovate beyond traditional cosmetics and household products, delivering creative solutions tailored to evolving consumer needs. About the Role As the Senior Regulatory Affairs Manager, you will ensure regulatory compliance for cosmetic, OTC, dietary supplement, and medical device products in North America—from concept to market launch. You will oversee formula reviews, compliance documentation, claims approval, and labeling while keeping stakeholders informed of emerging regulations. Key Responsibilities Partner with cross-functional teams to ensure regulatory compliance throughout product development and launch. Maintain adherence to company ingredient policies and applicable regulations (FDA, Health Canada, EPA, etc.). Review and approve product claims, ensuring consistency across labels, advertising, and consumer communications. Oversee North American artwork compliance. Manage U.S. regulatory submissions, including FDA drug listings, establishment registrations, supplement notifications, WERCS, and state pesticide registrations. Monitor evolving federal and state regulations impacting cosmetics, personal care, and OTC products. Implement regulatory updates, including state-specific requirements (e.g., California). Preferred Qualifications Hybrid work schedule (3 days onsite per week). Bilingual in English/Korean (preferred but not required). Minimum Qualifications Bachelor's degree in a scientific discipline. 8+ years of Regulatory Affairs experience, preferably in skincare/personal care (including OTC). Experience in product development (strongly preferred). Expertise in claim substantiation for cosmetics, personal care, and OTC products. In-depth knowledge of compliance standards (FDA, Health Canada, EPA, FTC, cGMP, ISO, etc.). Strong technical writing and verbal communication skills. Ability to collaborate effectively across teams and present regulatory insights clearly. Highly organized, detail-oriented, and adaptable to shifting priorities. Proficiency in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint). #J-18808-Ljbffr MDAEdge