Job Title: Manager – Regulatory Affairs (Artwork Management)
Location: Bengaluru, India
Department: Regulatory Affairs
Employment Type: Full-Time
Role Summary:
The Manager – Regulatory Affairs (Artwork Management) is responsible for overseeing the end-to-end artwork development process for labeling and packaging components, from brief initiation to final release. This role ensures high-quality, compliant artwork delivery, coordinating with cross-functional teams and external vendors while driving process improvements and operational excellence. The role balances hands-on execution with team supervision, making it critical for efficient regulatory labeling operations.
Key Responsibilities:
Manage the complete artwork development lifecycle, ensuring timely delivery and compliance with regulatory, legal, and corporate standards.
Serve as the primary liaison between PMO, Regulatory Affairs, Marketing, Packaging, Quality, Supply Chain, and external vendors.
Validate project briefs and collaborate with cross-functional teams to resolve discrepancies.
Oversee project timelines, resource planning, and progress tracking for multiple concurrent labeling projects.
Coordinate review and approval of labeling content and artwork in internal systems.
Drive process improvements related to artwork workflows, digital tools, and operational efficiency.
Conduct Root Cause Analyses (RCAs) and implement Corrective and Preventive Actions (CAPA) as needed.
Maintain artwork issue logs and participate in escalation and content lock meetings.
Manage Veraciti and other artwork system issues, implementing solutions and technology enhancements.
Create and maintain training documentation and onboard new hires on artwork management systems and processes.
Supervise and support Artwork Controllers, ensuring task completion during peak periods.
Track and report project status, risks, and milestones to stakeholders consistently.
Conduct design-to-press assessments, color management feasibility checks, and job resource planning.
Support system and process quality improvements and manage ad-hoc artwork-related requests.
Qualifications & Experience:
Bachelor’s degree in Life Sciences, Business, Packaging Technology, or related field.
10+ years of experience in labeling design, proofreading, coordination, regulatory affairs, packaging, and project management within pharmaceutical, consumer health, 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 under strict deadlines.
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 (TVT, GlobalVision, InformCC) and regulatory content validation.
Six Sigma Green Belt certification or equivalent continuous improvement experience.
PMP certification or formal project management training is a plus.
Excellent communication, problem-solving, and organizational skills.
Why Join:
This role provides the opportunity to drive excellence in artwork management, ensure regulatory compliance, and contribute to high-quality product labeling and packaging across global markets. You will work with cross-functional teams and external partners, improving processes while delivering strategic regulatory impact.
Equal Opportunity Statement:
We are an equal opportunity employer committed to diversity, inclusion, and fair employment practices. Qualified applicants will be considered regardless of race, gender, religion, sexual orientation, disability, or veteran status.
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