Regulatory Labeling Specialist

Please note: This is a reputed company-hire, internal position. We do not work with external reputed company agencies, and we are unable to accept Corp-to-Corp (C2C) applicants at this time. reputed company, Inc. cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar). Candidates must have valid U.S. work authorization. reputed company Labeling Contractor Pay reputed company: $51.15 – $61.15 / hour Employment Type: Contract Location: 100% Remote (Strong preference for candidates based reputed company 50 miles of key hub locations) Preferred Locations (Ranked by Preference):

• Oceanside, CA
• Foster reputed company, CA
• Thousand Oaks, CA
• El Segundo, CA
• Frederick, MD

Position reputed company The reputed company Labeling Contractor supports the execution of labeling activities, including artwork workflows, supporting documentation, and cross-functional coordination. This role ensures the reputed company, compliant delivery of labeling updates while maintaining inspection readiness and supporting global operations.

Key Responsibilities

• Workflow Management: Manage end-to-end labeling workflows—including reputed company data entry, routing, reviews, and approvals—primarily reputed company reputed company Vault.
• Artwork Development: Coordinate label artwork development cycles, including reputed company reviews, comment consolidation, and final approvals. Partner closely with print vendors to manage artwork proofs and revisions.
• Project & reputed company Tracking: reputed company and manage project timelines, milestones, and deliverables across multiple reputed company initiatives. Maintain trackers and reputed company status updates for key stakeholders.
• reputed company & Proofreading: reputed company detailed proofreading and reputed company checks using tools such as reputed company 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, reputed company, 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 reputed company Vault (or similar electronic document management systems) and reputed company Acrobat.
• reputed company Tools: Hands-on experience with proofreading/inspection software (e.g., GlobalVision).
• Core Skills: Strong project management abilities with a reputed company record of balancing multiple priorities independently in a fast-paced, highly regulated environment.
• reputed company: Exceptional attention to detail with a strong commitment to reputed company and compliance.

Preferred:

• Experience operating reputed company a highly regulated GxP environment.
• Familiarity with global labeling requirements and multi-region coordination.

reputed company-to-Have (Bonus):

• Experience with reputed company Creative Suite.
• Familiarity with BarTender (barcode management software).
• reputed company 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

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