Sr. Specialist - Regulatory Affairs - Operations 4C

Overview

Sr. Specialist (Band 4C) responsible for overseeing global regulatory master data management operations in RIM systems for data quality, compliance, and adherence to MDM standards.

What you'll do

• Oversee dossier lifecycle using Veeva Vault Active Dossier across current, submitted, and superseded product documents.
• Oversee automated generation and calculation of dossier records linked to regional submissions and global content plans.
• Manage Active Dossier templates, object lifecycles, and country-level generation rules in Veeva Vault.
• Support cross-functional verification by partnering with regulatory authors, CMC teams, and submission managers to resolve document-type discrepancies.
• Ensure audit and compliance readiness by tracking local-language translations, source files, and status history across international markets.
• Guide entry, updating, maintenance, and archival of data entry/correction requests from RIM system users globally.

What you'll need

• 10+ years in regulatory data management.
• Experience developing and maintaining master data management standards for regulatory systems.
• Experience with Six Sigma methodology.
• Experience supporting and working with tools and systems used in the Regulatory Affairs environment.
• Experience leading data governance, master data management, process improvement, or transformation initiatives.
• Expertise in regulatory and data reporting systems and MS Excel.
• Bachelor’s degree required.

Details

• Location: Mumbai, India (as provided in the ATS location line).
• Work mode: Hybrid (Remote Type: Hybrid) and scheduled for a day shift in India.