Manager - Regulatory Affairs (Artwork Management)

Role Summary
The Regional / Senior Artwork Controller is responsible for managing the end-to-end artwork development process (brief → final release) for packaging and labeling components within the region. This role ensures timely delivery of high-quality, compliant artwork by coordinating cross functional teams and external vendors, while driving process improvements and maintaining operational excellence. This role combines hands-on execution with team supervision.

Key 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.
• Share project insights for dashboards and analytics; contribute to KPI reviews and compliance initiatives.
• Gather requirements for new regional jobs and assess resources requirements and provide job quotations when requied.
• 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.

Qualifications & Experience:

• 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.