Posted Jul 25, 2026

Regulatory Labeling Specialist

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Please note: This is a direct-hire, internal position. We do not work with external staffing agencies, and we are unable to accept Corp-to-Corp (C2C) applicants at this time. ATR International, Inc. cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar). Candidates must have valid U.S. work authorization. Commercial Labeling Contractor Pay Rate: $51.15 – $61.15 / hour Employment Type: Contract Location: 100% Remote (Strong preference for candidates based within 50 miles of key hub locations) Preferred Locations (Ranked by Preference): • Oceanside, CA • Foster City, CA • Thousand Oaks, CA • El Segundo, CA • Frederick, MD Position Summary The Commercial Labeling Contractor supports the execution of labeling activities, including artwork workflows, supporting documentation, and cross-functional coordination. This role ensures the timely, compliant delivery of labeling updates while maintaining inspection readiness and supporting global operations. Key Responsibilities • Workflow Management: Manage end-to-end labeling workflows—including form data entry, routing, reviews, and approvals—primarily within Veeva Vault. • Artwork Development: Coordinate label artwork development cycles, including proof reviews, comment consolidation, and final approvals. Partner closely with print vendors to manage artwork proofs and revisions. • Project & Timeline Tracking: Track and manage project timelines, milestones, and deliverables across multiple concurrent initiatives. Maintain trackers and provide status updates for key stakeholders. • Quality & Proofreading: Perform detailed proofreading and quality checks using tools such as Adobe Acrobat and GlobalVision. • Change Implementation: Support change execution, including obsolescence tracking and phase-in/phase-out coordination. • Compliance & Documentation: Maintain labeling documentation to ensure strict compliance with internal procedures and Good Documentation Practices (GDP). • Cross-Functional Collaboration: Partner effectively with Regulatory, Quality, Supply Chain, and global stakeholders across multiple time zones. • Risk Management: Proactively identify risks, manage issues, and escalate delays or concerns as needed. Qualifications Required: • Experience: 3–5+ years in pharmaceutical/biotech labeling, regulatory operations, or supply chain. • Systems: Familiarity with Veeva Vault (or similar electronic document management systems) and Adobe Acrobat. • Quality Tools: Hands-on experience with proofreading/inspection software (e.g., GlobalVision). • Core Skills: Strong project management abilities with a track record of balancing multiple priorities independently in a fast-paced, highly regulated environment. • Mindset: Exceptional attention to detail with a strong commitment to quality and compliance. Preferred: • Experience operating within a highly regulated GxP environment. • Familiarity with global labeling requirements and multi-region coordination. Nice-to-Have (Bonus): • Experience with Adobe Creative Suite. • Familiarity with BarTender (barcode management software). • Direct experience working with print vendors and packaging components. Key Competencies • High accuracy and extreme attention to detail • Proactive problem-solving and risk escalation • Strong cross-functional communication and organization • Ability to collaborate seamlessly across global teams and time zones