Regulatory Labeling Specialist
5 months ago
Universal Beauty Products, Inc. has been dedicated to making the world's finest, high-quality products in the beauty and personal care industry. Our customers, both large and small, are based in countries all over the world, and as a company, we pride ourselves on our commitment to producing innovative and performance driven products. We are under new management and growing, so now is a great time to join our team. Please note this is an on-site position.
In addition to competitive pay and benefits, we provide a safe and inclusive work environment that appreciates diversity, promotes development and allows our associates to be their authentic selves.
The Regulatory Labeling Specialist ensures finished product labels are compliant with FDA labeling laws and 21 CFR regulations, minimizing the exposure of the company to regulatory action including recalls, jeopardy of third party certifications, customer and consumer complaints.
Duties/Responsibilities:
- Under general supervision, responsible for aligning product labeling content with state and federal regulations
- Review, verify and complete packaging submissions to authorize label related content based on regulations and product claims
- Knowledge and understanding of FDA product codes and product class structure, Quality Management Systems and Good Manufacturing Practices
- Manage the revision history of all product labeling and coordinate the translation of approved product labeling into the required languages of international markets while upholding all applicable requirements
- Coordinate and facilitate communication and collaboration with external partners, such as suppliers and contract manufacturers, to ensure compliance with all regulatory requirements
- Assist with reviewing social media content for alignment with regularity compliance.
- Conduct internal audits of files, processes and databases and making process improvements as necessary.
- Create and maintain detailed documentation and reports related to scientific and regulatory affairs, ensuring accuracy and completeness
- Develop and maintain strong relationships with regulatory agencies, staying informed on any changes or updates that may impact our products
- Collaborate with cross-functional teams, including R&D, marketing, graphic design, quality, purchasing and legal, to ensure compliance across all departments for regulatory requirements
- Other duties as requested by management
Required Skills/Abilities:
- 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 21CFR Labeling Requirements
- Strong verbal and written communication skills
- Excellent interpersonal, and organizational skills and good attention to detail required
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