Regulatory Labeling Specialist

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 Work Location: Hybrid Must be located within commuting distance of one of the following site hubs: Foster City, CA | Oceanside, 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. 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 #J-18808-Ljbffr ATR International