ClinChoice - Regulatory Affairs- Labeling Artwork Consultant
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Requirements
• Bachelor’s degree in Life Sciences, Business, Packaging Technology, or related field; • 10+ years in labeling design, proofreading, coordination, regulatory, packaging, and project management within consumer health, pharmaceutical, or medical device industries. • Strong knowledge of global regulatory requirements for product labeling and packaging. • Proven ability to manage multiple projects and cross-functional teams in a deadline-driven environment. • Hands-on experience with PLM and electronic artwork systems (e.g., Agile, GLAMS, Loftware, Veraciti, Veeva). • Expertise in Adobe Creative Suite (Illustrator, InDesign, Photoshop, Acrobat Pro). • Familiarity with pre-press and print processes (CMYK, Pantone, dielines, bleed, etc.). • Skilled in proofreading tools (e.g., TVT, GlobalVision, InformCC) and regulatory content validation. • Six Sigma Green Belt certification or equivalent experience in continuous improvement. • Excellent communication, problem-solving, and organizational skills. • PMP certification or formal project management training is a plus. • Key Words: Regulatory Affairs, Artwork, Labeling design, proofreading • Key Words: • #LI-PB1 #LI-REMOTE
Responsibilities
• Manage the end-to-end artwork development process from initiation through approval and release, ensuring timely delivery of high-quality labeling components. • Act as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors/agencies. • Validate briefs for accuracy and completeness; collaborate with cross-functional teams to resolve discrepancies. • Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects. • Coordinate review and approval of labeling content and artwork in internal systems, ensuring compliance with regulatory, legal, and corporate standards. • Drive process improvements related to artwork development, approval workflows, and digital tools. • Investigate Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed. • Maintain artwork issue logs and attend escalation meetings to provide updates. • Identify inefficiencies and escalate to Hub Leads when required. • Participate in content lock meetings to ensure stakeholder alignment. • Manage Veraciti system-related issues and escalate appropriately. • Suggest and implement technology solutions for artwork and labeling processes. • Create, update, and maintain training documentation for systems and processes. • Supervise Artwork Controllers to ensure task completion and provide support during peak periods. • Onboard new hires on artwork management systems and end-to-end processes; conduct quarterly refreshers on best practices. • Provide guidance on escalation channels and support SMEs, Artwork Process Leads, Vendors, and Hub Leads with artwork production deployment. • Track and follow up on action items from cross-functional meetings. • Communicate project status, risks, and milestones consistently to stakeholders. • Attend regional project meetings (Kick-off, Overview, Alignment, Technical with Printer) and provide updates. • Gather requirements for new regional jobs and assess resources requirements and provide job quotations when required. • Conduct design-to-press color management assessments and feasibility consultations. • Monitor and maintain regional project timelines and costs; anticipate and resolve roadblocks. • Address process and executional quality issues; support system and process improvements. • Manage ad-hoc artwork-related requests and cascade process/system communications.
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