Vamshi Krishna Baline

• Developed and implemented a comprehensive delivery plan that enabled the successful completion of projects within budget and ahead of schedule.
• Monitored project progress and identified potential risks, mitigating issues that could cause project delays and cost overruns.
• Created automated reporting systems that tracked project milestones and enabled data-driven reports.
• Prepared and presented financial reports to senior management and external stakeholders.
• Led regulatory submissions and compliance initiatives, ensuring adherence to evolving industry standards and enhancing approval timelines.
• Led end to end Veeva Vault release management, planning, impact assessment, Validation, testing deployment.
• Coordinated with Veeva and internal teams for seamless releases.
• Developed and maintained reports and dashboards, identified data anamolies and ensured reporting accuracy.
• Collaborated with regulatory operations team and supported implementation of EMA regulatory data standards including ISO IDMP,SPOR, xEVMPD and electronic application forms (eAF) ensuring publishing process and submission process aligned with requirements.
• Monitored regulatory quality and tracked metrics across the deliverables with the agreed SLA/KPI agreement
• Directed Regulatory CMC submissions including Module 2 & 3 for INDs, NDAs, ANDAs, MAAs, variations, supplements, and amendments across US, EU, and ROW markets.
• Oversaw regulatory publishing activities (eCTD, NeeS, paper) ensuring dossier quality, compliance with ICH/regional guidelines, and timely submissions.
• Provided CMC and publishing strategy for new product development and lifecycle maintenance.
• Developed and implemented strategic regulatory frameworks, driving alignment with global regulatory requirements and improving operational efficiency.
• Managed a 30+ member team; provided coaching, mentoring, and performance management to achieve business goals.
• Implemented automated project tracking/reporting systems, improving efficiency and visibility.
• Led cross-functional teams to deliver strategic initiatives aligned with organizational goals.

• Managed preparation and submission of CMC sections for global filings (US, EU, ASEAN).
• Coordinated with publishing teams to ensure error-free and timely electronic submissions.
• Reviewed technical CMC documentation (manufacturing process, controls, analytical methods).
• Partnered with business teams to support market clearance by timely dossier submissions.
• Provided regulatory guidance and mentorship to new team members.
• Collaborated with external stakeholders to align regulatory strategies with business objectives, driving successful product launches and market access.

• Led regulatory publishing team for global submissions; created dossier structures, assigned documents, and performed document- and submission-level QC.
• Point of contact for troubleshooting publishing issues (validation errors, PDF compliance, hyperlinks/bookmarks).
• Delivered multiple submissions simultaneously while ensuring adherence to client timelines.
• Supervised junior associates, providing training and guidance on regulatory publishing best practices.
• Developed and implemented streamlined processes for regulatory submissions, significantly reducing approval timelines and improving resource allocation.

1. Ensure Dossier compilation and timely submission within Southeast Asian Region.

2. Assist in developing regulatory strategies.

3. Assist regulatory management in the implementation and delivery of CMC regulatory documentation

4. Handling and responding to a l product specific queries and submission documents to ministry of health.

• Compiled and submitted CMC sections of ANDAs and DMFs in CTD format to USFDA.
• Supported regulatory publishing of dossiers, ensuring format compliance and readiness for submission.
• Coordinated with R&D and QA teams to align submission strategy with product development.
• Conducted internal audits and dossier reviews to ensure quality and accuracy.