Job Description

Division
IRA
Job posted on
Aug 26, 2025
Employee Type
P-P8-Probationer-HO Executive
Experience range (Years)
0 - 0

Compilation and review of new registration dossiers as per country requirements. Review of Technical Documents (EDMF, Product Development Report, BMR, BPR, Analytical Method Validation Report, Specification-STP, Stability Report, BE Study Report etc.) Compilation and review of dossiers as per requirements for ROW Countries. Compilation of deficiency responses of new product submission. To prepare and submit the variation for post approval changes. To communicate and follow up with overseas regulatory team /agent/ distributors to ensure timely filing of new submission or variation. To review various artworks & comments for ongoing commercial supply & products for the new launch. To prepare and maintain various registration Data base & updating at Central Depository Compilation and Review of commercial and supporting documents * To coordinate with GDSO & vendor to get DME, GMP certificate etc. for filing purpose.