We are seeking a detail-oriented and proactive Regulatory Technician to join our Quality Assurance team. This role is responsible for ensuring that product labels and packaging meet all internal standards and external regulatory requirements, including FDA, international guidelines, and branding specifications. The ideal candidate has a strong understanding of regulatory labeling in the dietary supplement or pharmaceutical industry and can manage multiple projects while working cross-functionally with internal departments and external partners.
Key Responsibilities
Ensure product labels and packaging comply with local, state, federal, and international regulatory requirements.
Apply brand style guides and formatting standards to create and update product labeling.
Draft and release engineering change orders through the company’s document control system.
Collaborate with departments such as Marketing, R&D, Quality, and Engineering on labeling and packaging initiatives.
Support product development projects by managing labeling strategies from concept to final approval.
Review and proofread product artwork and labeling, including primary, secondary, and multi-lingual materials.
Contribute to ongoing process improvements and maintain accurate records of all changes.
Communicate regulatory risks and propose solutions to ensure compliance in all labeling-related activities.
Stay current on regulatory trends and best practices, particularly in the dietary supplement space.
Assist with regulatory inspections and audits related to labeling and documentation.
Support regulatory advertising and promotional reviews, ensuring compliance with claims regulations.
Qualifications
High school diploma or equivalent required; Associate’s or Bachelor’s degree in a related field is preferred.
1–3 years of experience in regulatory affairs, quality assurance, or a similar role in the dietary supplement, food, or pharmaceutical industry.
Familiarity with FDA regulations (21 CFR Part 111) and international labeling requirements.
Strong attention to detail with excellent proofreading and documentation skills.
Proficiency with Microsoft Office and experience using ERP/document control systems.
Bilingual (English/Spanish) strongly preferred.
Ability to work independently, manage multiple priorities, and communicate effectively across departments.