Sumit D. Loute

Milestone & Risk Management Stakeholder Communication & Coordination Regulatory & Operational Oversight Performance & Resource Optimization

Project Management & Execution

• Developed and managed full-scale project timelines and milestones for Injectable and OSD formulations targeting the US market; ensured timely dissemination of activities to key stakeholders throughout the project lifecycle.
• Led end-to-end branded generics projects, securing stakeholder buy-in and aligning strategies with Regulatory Affairs and Clinical teams.
• Directed injectable drug development projects from initiation to launch, managing scope, timelines, and budgets effectively.
• Monitored project progress through milestone mapping, tracking Actual vs. Latest Estimate (LE), and analyzing baseline deviations; escalated critical issues to senior management.
• Conducted proactive risk identification and maintained comprehensive risk registers to mitigate potential delays.
• Facilitated seamless communication via regular meetings (Kick-off, Phase Gate, Updates, Closure), circulated Minutes of Meetings (MOM), and ensured follow-up on assigned responsibilities.
• Coordinated with internal teams, external partners, and vendors to drive project success and maintain alignment with organizational objectives.
• Oversaw regulatory submissions, confidentiality agreements (CDA), business case approvals, and material readiness for project initiation.
• Prepared and tracked detailed project timelines, ensuring all Single Points of Contact (SPOCs) met defined objectives.
• Successfully managed multiple projects simultaneously by prioritizing tasks based on urgency, resource availability, and strategic alignment.
• Designed, planned, and scheduled phases for large-scale projects, adjusting resources and timelines to maintain delivery targets

Program & Project Management
Managed strategic programs within the Strategy Department, overseeing project initiation, planning, execution, and control of timelines and milestones. Delivered end-to-end lifecycle projects including launches, changes, transfers, and divestments, ensuring timely implementation and risk mitigation. Coordinated cross-functional teams and external partners, organized key stakeholder meetings, and maintained full visibility of project progress. Supported PMO initiatives to enhance capability through training, communication, and process improvements. Handled vendor negotiations, sourcing, and contracting (CRO/CMO), while driving projects from conception to registration and market launch. Ensured inventory readiness, managed regulatory submissions, and implemented CAPA to prevent delays.

• Complex Injectable Projects: from initiation to filing. Viz ANDA, 505B2.
• Provide and co-ordinate cross-functional planning, development and tracking of project plans and contingencies considering time, cost, quality and strategy.

• Technology transfer of Oral solid Dosage Form (Tablets, Capsules, Solid Suspensions).
• Trouble shooting on the commercial product issues.