Assistant Manager, Labeling Reviewer

About the role

Assistant Manager, Labeling Reviewer at Hcfa. Define and execute labeling strategies for India, EU, Canada, and ROW markets.

What you'll do

• Define and execute labeling strategies for India, EU, Canada, and ROW markets
• Ensure alignment of local labeling with Core Data Sheet (CDS) / Company Core Safety Information (CCSI)
• Drive harmonization of labeling content across regions while addressing country-specific requirements
• Review labeling content as per regulatory requirements for India, EU, Canada, and ROW (Asia, Africa, MENA, CIS, LATAM) markets
• Ensure labeling content aligns with approved dossiers, SmPC, PI, or local regulatory approvals

What you need

• Regulatory affairs
• Pharmacovigilance
• Documentation
• SOP writing
• Communication
• Any graduate