Assistant Manager, Labeling Reviewer
AhmedabadFull-timeMid levelPosted over a month ago
Mid-level pharma role at Hcfa in Ahmedabad.
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