Assistant Manager, Labeling Reviewer

Job Description:

Responsibilities

•  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. 
•  Maintain consistency in labeling format, terminology, and design templates across markets. 
•  Ensure compliance with: 
•  CDSCO regulations and labeling requirements 
•  EU Guidelines (EMA, QRD templates) 
•  Health Canada labeling requirements 
•  Country-specific regulations for ROW markets (Asia, Africa, LATAM, MENA, CIS) 
•  Artwork Management