Senior Regulatory Affairs Associate- Labeling Strategy

📋 Description

• Develop, maintain, and update global labeling documents, including Company Core Data Sheets (CCDS)
• Manage post-approval labeling activities, including artwork updates, safety variations, xEVMPD
• Evaluate change-control requests affecting medicinal products in registered markets and assess
• Coordinate the review and approval of printed packaging components, ensuring compliance with
• Manage SPL-related activities, troubleshoot technical issues, and oversee labeling document reviews
• Monitor artwork change requests, coordinate artwork creation and translation processes, and

🎯 Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or a related field, or equivalent
• 7–8 years of experience in pharmaceutical regulatory affairs, with demonstrated expertise in
• In-depth knowledge of labeling regulations and guidelines across major markets, including the
• Hands-on experience with CCDS-related submissions, safety variations, labeling lifecycle
• Proficiency in Structured Product Labeling (SPL), including document preparation, review, and
• Experience using regulatory documentation and document management systems to manage labeling

🎁 Benefits

• Remote work: Remote working arrangement based in India.
• Professional development: Opportunities to deepen expertise in global regulatory affairs, labeling
• International collaboration: Work with cross-functional teams supporting regulatory activities
• Career growth: Opportunities to expand technical knowledge and contribute to regulatory strategy
• Meaningful impact: Help maintain the accuracy and compliance of pharmaceutical labeling that