At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive workplace that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Key Responsibilities
• Tracks, collects and reviews all components for routine submissions to Health Authorities
• Interacts with responsible parties to ensure quality submission documents for routine submissions
• Troubleshoots issues found in components received and coordinates with responsible parties for clarification or revision
• Builds and manages dossier structures in Lorenz Docubridge for global CMC submissions
• Builds, compiles, and publishes eCTD submissions in-house using Veeva Vault RIM
• Distributes, tracks,



and archives non-eCTD submissions globally
• Drafts eCTD content plans for CMC submissions
• Independently prepares Cover Letters, FDA Forms, and submission content plans for routine maintenance and Investigational submissions
• Performs submission verification on published submissions to confirm eCTD compliance
• Maintains and updates submission tracking data in Verity (Veeva Vault) — planned, in-progress, and submitted submissions
• Lead contact to ensure Literature References are correctly maintained in Verity (Veeva Vault)
• Assists with translation document management activities
• Supports process and system improvement initiatives (e.g., submission tracking tools, workflow enhancements)
• Other miscellaneous regulatory operational activities as needed (e.g., US export waivers)

Qualifications & Experience
• BA/BS degree, science/technology field preferred
• 6+ years relevant submissions and publishi

📌 Submission Senior Specialist (Hyderabad)
🏢 Bristol-Myers Squibb
📍 Hyderabad