Regulatory Affairs- Labeling Artwork Consultant

Regulatory Affairs- Labeling Artwork Consultant

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Regulatory Affairs- Labeling Artwork Consultant for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Job Description

Artwork Controller

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 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.

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.

Key Words: Regulatory Affairs, Artwork, Labeling design, proofreading

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