What are the responsibilities and job description for the Regulatory Affairs Specialist position at Mario Badescu Skin Care, Inc.?
Regulatory Affairs Specialist – Global Compliance
Location: Edison, NJ
Mario Badescu Skin Care is seeking a Regulatory Affairs Specialist to play a critical role in ensuring global compliance while supporting business growth. This position will oversee regulatory activities across key international markets, including USA, Southeast Asia, Indonesia, LATAM, and the EU/UK, ensuring compliance with regional regulations and facilitating market expansion.
Responsibilities:
Global & U.S. Regulatory Compliance & Product Registration
• Work with The Good Face Project screening software and international regulatory teams to ensure compliance with U.S. and global cosmetic regulations, including MOCRA (Modernization of Cosmetics Regulation Act), ASEAN Cosmetic Directive, BPOM (Indonesia), COFEPRIS (Mexico), ISP (Chile), INVIMA (Colombia), DIGEMID (Peru), and EU Cosmetic Regulation (EC) No 1223/2009.
• Provide regulatory support for new product registrations, Certificates of Free Sale, labeling compliance, SDS authoring, and PIF preparation in alignment with country-specific registration requirements.
• Work closely with distributors, retailers, and registration agencies to facilitate product registration and market entry in the U.S., Southeast Asia, Indonesia, LATAM, and the EU/UK.
• Manage and maintain documentation required for regulatory submissions, including Health Authority filings, safety reports, and compliance audits.
• Ensure MOCRA compliance for U.S. products, including adverse event reporting, facility registration, product listing, and safety substantiation.
Regulatory Strategy & Compliance Management
• Develop and implement regulatory strategies for launching new products and maintaining existing product compliance across multiple international markets.
• Stay current on changing regulations, emerging compliance trends, and evolving ingredient restrictions across U.S. (MOCRA), ASEAN, Indonesia, LATAM, and the EU/UK to ensure adherence throughout the product lifecycle.
• Anticipate regulatory obstacles and risks across regions and provide proactive solutions for compliance challenges.
• Maintain Regulatory Affairs filings and Health Authority communications in an organized and efficient manner, both electronically and on paper.
Labeling, Claims, and Marketing Compliance
• Review and approve product labels, kit packaging, and marketing collateral for compliance in the U.S. and international markets.
• Work closely with the Creative and Marketing teams to review, comment on, and approve all product claims, ensuring compliance with MOCRA and region-specific advertising and labeling laws.
• Conduct regulatory risk assessments and provide alternative solutions for claim language where necessary.
Testing & Safety Compliance
• Work with Product Development and R&D teams to ensure that all new formulations comply with regional safety, efficacy, and regulatory requirements.
• Manage and review third-party testing reports for claims substantiation and safety validation.
• Maintain and create regulatory data for all raw materials, ingredients, and formulations in compliance with MOCRA and international standards.
Cross-Functional Collaboration & Representation
• Act as the Regulatory Affairs representative in all applicable internal meetings and global regulatory discussions.
• Provide regulatory guidance to cross-functional teams, ensuring that product development aligns with MOCRA, U.S. FDA regulations, and international market standards.
• Collaborate with distributors and government agencies to facilitate product approvals, respond to regulatory inquiries, and support compliance audits in key global markets.
Requirements:
• 5 years of experience in the cosmetic or personal care industry, including 5 years in Regulatory Affairs.
• Bachelor’s degree in Chemistry, Biology, or related science required; Master’s degree preferred.
• In-depth knowledge of U.S. cosmetic regulations, including MOCRA (Modernization of Cosmetics Regulation Act), FDA, FD&C Act, Fair Packaging and Labeling Act, and state-level regulations.
• Expertise in international cosmetic regulatory frameworks, including:
• EU (Regulation (EC) No 1223/2009)
• ASEAN Cosmetic Directive & individual country regulations (e.g., BPOM in Indonesia, HSA in Singapore, FDA in the Philippines, TGA in Australia)
• LATAM (COFEPRIS in Mexico, ISP in Chile, INVIMA in Colombia, DIGEMID in Peru, etc.)
• Strong understanding of OTC and cosmetic product compliance.
• Experience managing global regulatory submissions, safety assessments, and product compliance documentation.
• Ability to work cross-functionally with Marketing, Product Development, Legal, and International Sales teams.
• Highly detail-oriented, organized, and proactive in anticipating regulatory challenges.