Regulatory Affairs – Labelling (EU & US Market)

Experience: 4+ Years
Qualification: M.Pharm – Regulatory Affairs / Quality Assurance Preferred
Employment Type: Full-Time
Industry: Pharmaceutical Manufacturing / Regulatory Affairs

Role Summary

Manage pharmaceutical labelling activities for EU and US markets, ensuring compliance with EMA, FDA, and global regulatory requirements. The role involves artwork review, regulatory documentation, lifecycle management, and cross-functional coordination.

Key Responsibilities

• Prepare, review, and approve pharmaceutical labelling and artwork for EU and US markets.
• Ensure compliance with EMA, FDA, and country-specific regulatory requirements.
• Manage labelling lifecycle activities, variations, updates, and change controls.
• Coordinate artwork approvals and implementation of approved labelling changes.
• Support regulatory submissions, product launches, and post-approval changes.
• Prepare and maintain regulatory documentation with proper version control.
• Respond to regulatory queries and support inspections and audits.
• Collaborate with Regulatory Affairs, QA, Packaging Development, and Manufacturing teams.

Required Skills

• Regulatory Affairs & Pharmaceutical Labelling
• EU & US Regulatory Compliance
• FDA & EMA Guidelines
• Artwork Review & Approval
• Regulatory Documentation & Submissions
• Change Control & Lifecycle Management
• Pharmaceutical Formulations
• Strong Attention to Detail & Analytical Skills
• Cross-Functional Collaboration