Sista Venkat Naresh

Manager Regulatory Information Management @Novartis

Hyderabad, IN

As a member of the Regulatory Information Management Team, responsible to implement processes and procedures to assure sustained compliance, at the global, regional and local level, with Health Authority, management and reporting of the regulatory status and compliance.* Ensures the implementation of RA policies and procedures to sustained compliance with HA regulations and internal Novartis policies* Monitors HQ and Country Organization compliance with internal procedures governing regulatory information management, compliance reporting and HA commitment data management activities at the global, regional and local level.* Expert in RA Systems and related tools that support regulatory information management processes worldwide.* Ensures training is updated and maintained and provides training as needed.* Work with global RIM colleagues in Process Improvement and Excellence to address potential quality issues and emerging compliance concerns and recommend solutions.* Provides input to the regulatory strategy and drives implementation of RA systems in collaboration with subject matter experts and IT.* Lead the development of new reports using business analytic tools like Power BI, Qlik sense for various submission types to report compliance.* Manage deviations/incidents/Quality Events/CAPAs in QEM system.* Support or lead the preparation for internal or global audits.* Represents RA in relation to HA registration and regulatory information management processes and systems during inspections in partnership with functional area experts.* Contributes to the continued development and monitoring of metrics related to Regulatory Information Management and Compliance Reporting to drive consistent quality.

ICRI

Master's degree, Clinical research