Regulatory Compliance Specialist
1 week ago
We are a leading manufacturer of high-quality beauty and personal care products, dedicated to delivering innovative and performance-driven solutions to our customers worldwide.
Job SummaryWe are seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring that our finished product labels comply with FDA labeling laws and 21 CFR regulations.
Key Responsibilities- Regulatory Compliance: Align product labeling content with state and federal regulations, minimizing the exposure of the company to regulatory action.
- Label Review and Verification: Review, verify, and complete packaging submissions to authorize label-related content based on regulations and product claims.
- Regulatory Knowledge: Possess knowledge and understanding of FDA product codes and product class structure, Quality Management Systems, and Good Manufacturing Practices.
- Label Management: Manage the revision history of all product labeling and coordinate the translation of approved product labeling into required languages for international markets.
- Collaboration and Communication: Coordinate and facilitate communication and collaboration with external partners, such as suppliers and contract manufacturers, to ensure compliance with all regulatory requirements.
- Internal Audits: Conduct internal audits of files, processes, and databases and make process improvements as necessary.
- Documentation and Reporting: Create and maintain detailed documentation and reports related to scientific and regulatory affairs, ensuring accuracy and completeness.
- Regulatory Agency Relations: Develop and maintain strong relationships with regulatory agencies, staying informed on any changes or updates that may impact our products.
- Cross-Functional Collaboration: Collaborate with cross-functional teams, including R&D, marketing, graphic design, quality, purchasing, and legal, to ensure compliance across all departments for regulatory requirements.
- 5 years minimum working experience in Regulatory Label Development and/or Regulatory Compliance.
- 3+ years' experience working in a CPG environment.
- Bachelor degree preferred in a Science-related field.
- Experience evaluating regulatory risk.
- Experience in project management using critical thinking and problem-solving skills to deliver results.
- Working/expert knowledge of FDA 21 CFR Labeling Requirements.
- Strong verbal and written communication skills.
- Excellent interpersonal, and organizational skills, and good attention to detail required.
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