Kuppaswamy Naidu K

• Provide leadership and strategic direction for the Submission Management sub-team, aligning with overall goals.
• Manage team performance, ensuring tasks are completed efficiently and to high standards.
• Guide the team through complex submissions, offering support and ensuring clear communication.
• Monitor progress, quality, and timeliness to meet deadlines and maintain submission quality.
• Ensure accountability for results, addressing challenges to maintain optimal performance.
• Streamline submission processes by aligning activities across functions to improve operations.
• Contribute to resource planning, aligning team needs with submission goals. Coordinate training programs to promote continuous learning and team development.

• Oversee submissions in Veeva Vault, managing records (Registration, Submission, SCP), and ensuring eCTD publishing compliance.
• Manage SMRA responsibilities, verify eCTD outputs for accuracy, and submit through Health Authority (HA) gateways.
• Address HA inquiries in Veeva Vault, documenting approvals and registrations.
• Lead the data migration of sponsor documents and regulatory submissions into Veeva Vault RIM.
• Test and implement NeeS submissions in Veeva Vault RIM, ensuring compliance.

• Collaborate with R&D to ensure timely, submission-ready documents.
• Perform quality checks and validate eCTD outputs for compliance before submission.
• Train new joiners on Veeva Vault and eCTDmanager, ensuring proficiency in submission workflows.

• Execute submissions per project plan and timelines, ensuring high-quality outcomes.
• Manage procurement, dossier compilation, publishing, and dispatch to RA or HA gateways, especially for direct submissions.
• Compile and dispatch applications throughout the regulatory lifecycle, ensuring compliance.
• Create and update records in the RIM system for accurate submission documentation.
• Track submissions, documenting HA inquiries, approvals, and registration details.
• Manage approval and registration details within Veeva Vault RIM.
• Perform quality checks, validate eCTD outputs, and submit through the appropriate HA gateway.

• Lead the Publishing team by assigning tasks, updating trackers, and ensuring smooth publishing execution.
• Provide training and mentorship, ensuring team proficiency in publishing tasks.
• Publish submissions in eCTD, NeeS, and paper formats for various markets using eCTDManager.
• Create binders and manage workflows in Veeva Vault to streamline processes. Archive eCTD submissions in Veeva Vault, and update Veeva RIMS for proper documentation and compliance.
• Prepare and review training materials for team development and best practices.
• Organize client meetings to understand requirements, and forecast publishing activities.
• Provide monthly updates to management on publishing progress and concerns.

• Publish submissions in eCTD, NeeS, and paper formats for multiple markets, including the US, HC, EU, GCC, AU, South Africa, and others.
• Manage team tasks, ensuring efficient execution, and mentoring junior associates.
• Serve as the PoC for client discussions, addressing submission requirements, issues, and updates.
• Handle pre- and post-publishing activities for NDA, IND, and IMPD submissions, ensuring compliance.
• Validate and resolve issues with eCTD and NeeS submissions for accuracy.
• Archive submissions and update RIMS for proper documentation.

• Training resources to onboard new team members and ensure they are proficient in publishing activities and regulatory submission processes.
• Publish submissions in Paper, NeeS, and eCTD formats, ensuring compliance with regulatory standards.
• Prepare eCTD submission requests for Adverse Event (AE) reports, including documentation and cover letters.
• Sign FDA forms, and prepare cover letters for AE report submissions.
• Validate and resolve issues in eCTD submissions, ensuring compliance and quality.
• Perform QC checks at both the document and submission levels to ensure accuracy.
• Submit AE reports to the U.S. FDA through the ESG gateway, ensuring timely and compliant submission.

• Prepare the Submission Planner for various submissions, ensuring that timelines and tasks are clearly outlined and managed.
• Perform pre-publishing activities, including hyperlinking and creating bookmarks, using various tools to ensure document compliance.
• Publish eCTD submissions using Insight Publisher, ensuring accuracy, and regulatory adherence.
• Manage post-publishing activities, including validation and external linking, to ensure submission quality and compliance.

• Handled data migration from databases like ORION and GREAT to the ORION Insight Manager (ORION v3.0 system), ensuring a smooth and accurate transition of data.

• Handled data migration from databases like ORION and GREAT to the ORION Insight Manager (ORION v3.0 system), ensuring a smooth and accurate transition of data.