DIVYA CHAWLA

• Management of the regulatory information data including Chemistry, Manufacturing and Control (CMC) of Medicinal Products/Vaccines/Devices/ Neutraceuticals which includes performing the data entry in the Veeva Vault
• Creation of Veeva objects like Event, Submissions, Regulatory objectives, Registrations, Core packages, Dispatches etc. for Marketing and Clinical Trial Application (CTA)
• Track and manage regulatory submissions, approvals, regulatory documents and their lifecycle states
• Creation of Submissions in the regulatory database to track labeling or quality or administrative changes for the US, ROW- Rest of the World and for the European Union region for National, Centralized, Mutual Recognition and Decentralized procedures
• Maintaining, tracking changes and managing the lifecycle state of a medicinal product including its packaging, manufacturing sites, storage conditions or shelf life, etc. in the regulatory database per the information received from the client
• Data remediation during QC audit of regulatory data within Vault RIM
• Manage and update events in Vault RIM that are sourced from Phenix or QMS
• Managing xEVMPD, IDMP submissions.
• Manage and respond to Health Authorities questions and commitments
• Support client with Importing regulatory dossier and their dispatch
• Support client with submission content plan (SCP), Reporting, etc

Management of the regulatory information data including Chemistry, Manufacturing and Control (CMC) of Medicinal Products/Vaccines/Devices/ Nutraceuticals which includes performing the data entry in the Veeva Vault. Creation of Veeva objects like Event, Submissions, Regulatory

Management of the regulatory information data including Chemistry, Manufacturing and Control (CMC) of Medicinal Products/Vaccines/Devices/ Nutraceuticals which includes performing the data entry in the Veeva Vault.

Management of the regulatory information data including Chemistry, Manufacturing and Control (CMC) of Medicinal Products/Vaccines/Devices/ Nutraceuticals which includes performing the data entry in the Veeva Vault