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Aarav Shetty
Global Regulatory Operations – Regulatory Data & Systems Manager
Global Regulatory Operations – Regulatory Data & Systems Manager
Aarav Shetty is a seasoned Regulatory Operations and CMC Lifecycle Management professional with 12+ years of global experience across Regulatory Affairs Operations, RIMS, submission publishing, and post-approval product lifecycle management. He specializes in global submissions (US, EU, UK, Middle East, ROW), regulatory data governance, and implementation of RIMS tools such as Veeva Vault, Documentum, Lorenz, and eCTD Express. Aarav has consistently led cross-functional teams, optimized regulatory workflows, and driven automation initiatives to improve compliance, efficiency, and operational excellence in large global pharma environments.
FORMERLY AT
Amgen
LOCATION
Hyderabad
AVAILABILITY
Full-time
Skills
Documentum
eCTD Express
GDMS
InSight Publisher
Lorenz Docubridge
Lorenz)
MS Office
Regulatory Data Systems
RIMS Platforms (InSight
SMRT
Veeva RIMS
Veeva Vault
Work Experience
Global Regulatory Operations – Regulatory Data & Systems Manager
Amgen
July 2025 – Present
- Provide regulatory process advisory and manage RIMS systems ensuring global data governance.
- Optimize regulatory system integrations and submission processes, including adoption of AI-based data administration and automation.
- Coordinate with cross-functional stakeholders to ensure timely execution and compliance adherence.
TECHNOLOGIES
Veeva Vault, Documentum, RIMS Platforms (InSight, Lorenz), Regulatory Data Systems, MS Office
Manager – Global Regulatory Affairs Operations
Genpact, India
June 2022 – July 2025
- Led global submission publishing using Veeva Vault and eCTD tools.
- Oversaw regulatory data maintenance and documentation workflows.
- Managed team performance, staffing, and resource planning.
- Ensured submission quality and alignment with global regulatory requirements.
TECHNOLOGIES
Veeva Vault, eCTD Express, GDMS, SMRT, MS Office
Manager – Global Regulatory Affairs Operations (AstraZeneca Account)
Tata Consultancy Services (TCS)
January 2018 – June 2022
- Established new publishing and submission management teams and led end-to-end submission activities for US, EU, UK, Australia, Middle East, and ROW markets.
- Monitored KPIs, ensured delivery accuracy, and optimized business processes to improve operational efficiency.
TECHNOLOGIES
Veeva Vault, Lorenz Docubridge, InSight Publisher, Veeva RIMS
