Senior Regulatory Affairs Associate- Labeling Strategy

About the role

We are seeking a Labelling Strategist to join our team in a Remote capacity. As a Senior Associate Regulatory Affairs professional, you will support the development and management of global labeling strategies that advance new treatments for patients. This position plays a key role in regulatory compliance, labeling lifecycle management, and cross-functional coordination across major markets.

What you'll do

• Develop, maintain, and update global labeling documents including CCDS, USPI, and regional labels for US, EU, Switzerland, Canada, Australia
• Manage all post-approval labeling activities including artwork updates, safety variations, xEVMPD submissions, and PSURs with strong attention to regulatory compliance
• Conduct Regulatory Impact Assessments for change controls raised for medicinal products in registered markets
• Coordinate artwork approval processes for printed packaging components, ensuring compliance with design and regulatory requirements for new products, new packs
• Demonstrate proficiency in SPL across all aspects and troubleshooting, and manage the review and approval of labeling in document management systems

What you need

• 7–8 yrs of experience
• Regulatory affairs
• Chemistry
• Documentation
• Communication
• B.Sc