Digital Regulatory Labeling Lead

WNS; Gurugram District; On-site; INR 900,000 - 1,200,000; Full time

Job summary

A leading consulting firm in Gurugram is looking for a professional to lead digital label transformation initiatives. The role involves coordinating with Drug Regulatory Affairs, Quality, Supply Chain, and IT to ensure compliance with regional regulatory requirements. The ideal candidate should have regulatory labeling experience and knowledge of structured content standards. This position offers a chance to significantly impact compliance and documentation processes in the industry.

Qualifications

• Experience in regulatory labeling and documentation.
• Familiarity with structured content standards (e.g., SPL, IDMP, HL7).
• Proficiency in transforming PDF/artwork into structured data formats.
• Ability to validate artwork against regulatory text and approvals.

Responsibilities

• Lead digital label transformation programs.
• Coordinate with multiple departments (Regulatory Affairs, Quality, IT).
• Define and manage digital standards and compliance risks.
• Manage intake prioritization and timelines.
• Oversee documentation and change control process.
• Ensure alignment with regional regulatory requirements.
• Escalate compliance risks.

Skills

Regulatory labeling experience

Structured content standards knowledge

Knowledge of transforming PDF/artwork

Ability to interpret labeling documents

Job description

Responsibilities

• Lead end-to-end digital label transformation program
• Coordinate with Drug Regulatory Affairs, Quality, Supply Chain, Packaging, and IT
• Define digital standards (e.g., structured XML, SPL, IDMP alignment)
• Manage intake prioritization and timelines
• Oversee documentation and change control process
• Ensure alignment with regional regulatory requirements
• Escalate compliance risks

Skills Needed

• Regulatory labeling experience. Interpret approved labeling documents (SmPC, PI, IFU, carton/label artwork)
• Knowledge of structured content standards (SPL, IDMP, HL7, etc.)
• Knowledge of transforming PDF/artwork into structured data (XML, JSON, database formats)
• Validate artwork against approved regulatory text