Manager – Regulatory Affairs (Artwork Management)
Location: Bengaluru, Karnataka, India
Employment Type: Full-Time
Experience Required: 10+ years in labeling, packaging, or regulatory affairs
Educational Qualification: Bachelor’s in Life Sciences, Business, Packaging Technology, or related field
Job Overview
We are seeking a Manager – Regulatory Affairs (Artwork Management) to oversee the end-to-end artwork development and labeling process for pharmaceutical and healthcare products. This role ensures high-quality, compliant, and timely delivery of artwork by coordinating cross-functional teams, external vendors, and internal stakeholders. The ideal candidate will combine hands-on execution with leadership skills, process improvement expertise, and project management capabilities.
Key Responsibilities
Artwork Development & Regulatory Compliance
Manage the full lifecycle of artwork development from brief initiation to final release, ensuring compliance with regulatory, legal, and corporate standards.
Validate briefs for accuracy and completeness; resolve discrepancies with Regulatory Affairs, Marketing, Packaging, and Quality teams.
Oversee timelines, resource planning, and progress tracking for multiple concurrent labeling projects.
Conduct content validation and proofreading to ensure artwork meets global regulatory requirements.
Team Management & Stakeholder Coordination
Supervise and support Artwork Controllers, including onboarding, training, and quarterly refreshers on best practices.
Act as a primary liaison between internal teams, external vendors, and PMO, facilitating smooth communication and timely issue resolution.
Participate in regional project meetings and escalate roadblocks when required.
Process Improvement & Quality Management
Drive continuous process improvements related to artwork development, approval workflows, and digital tools.
Conduct Root Cause Analyses (RCAs) and implement CAPA to resolve recurring issues.
Maintain artwork issue logs and provide updates during escalations.
Suggest and implement technology solutions to improve artwork and labeling efficiency.
Project & Cost Oversight
Track regional project timelines, costs, and resource requirements; provide job quotations as needed.
Conduct design-to-press color management assessments and feasibility consultations.
Contribute to KPI dashboards, compliance initiatives, and cross-functional reporting.
Required Skills & Competencies
10+ years in labeling design, regulatory content, packaging, and project management within pharmaceuticals, medical devices, or consumer health industries.
Strong knowledge of global regulatory requirements for product labeling and packaging.
Hands-on experience with PLM and electronic artwork systems (e.g., Agile, GLAMS, Loftware, Veraciti, Veeva).
Proficiency in Adobe Creative Suite (Illustrator, InDesign, Photoshop, Acrobat Pro).
Understanding of pre-press and print processes (CMYK, Pantone, dielines, bleed).
Skilled in proofreading tools (TVT, GlobalVision, InformCC) and regulatory content validation.
Six Sigma Green Belt or equivalent experience in process improvement.
Excellent communication, problem-solving, organizational, and leadership skills.
PMP certification or formal project management training is a plus.
Why Join
Lead critical artwork and labeling projects for global healthcare products.
Collaborate with cross-functional and regional teams, vendors, and regulatory authorities.
Drive process excellence, compliance, and digital transformation in artwork management.
Opportunity to work in a fast-paced, dynamic environment with career growth and leadership exposure.
Apply now to join as Manager – Regulatory Affairs (Artwork Management) and lead global labeling and artwork initiatives with impact, compliance, and excellence.
Explore more regulatory affairs, packaging, and project management opportunities at
thepharmadaily.com
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