Senior Regulatory Affairs Associate- Labeling Strategy
RemoteFull-timeMid levelPosted 3 weeks ago
Mid-level pharma role at Parexel International India safety services. Remote.
About the role
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
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
What you need
- Regulatory affairs