Senior Specialist - Regulatory Submissions

Bristol-Myers Squibb India Pvt Ltd; Hyderabad; On-site; INR 1,500,000 - 2,400,000; Full time

Job summary

Bristol-Myers Squibb India Pvt Ltd in Hyderabad seeks a Submission Senior Specialist to lead regulatory submissions across global programs. You will coordinate with cross-functional teams to ensure accurate eCTD content, prepare documents, and maintain submission tracking in Veeva Vault and related systems.

The role requires strong knowledge of CMC/Quality dossier sections, 6+ years in submissions, and excellent communication.

Qualifications

• BA/BS degree in science/technology field preferred.
• 6+ years submissions and publishing experience.
• Knowledge of CMC/Quality dossier sections.

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 in components 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.
• 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).
• 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.
• Other miscellaneous regulatory operational activities as needed.

Skills

CMC Knowledge

Global Regulatory

Attention to detail

Communication skills

Team collaboration

Education

BA/BS in science/tech

Tools

Veeva Vault RIM

Lorenz Docubridge

Microsoft Office

eCTD viewers

Job description

Submission Senior Specialist

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 environment 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 publishing experience

Key Competency Requirements

• Must have working knowledge of CMC/Quality dossier sections (e.g., Module 3 structure) to accurately compile and publish submission content
• Foundational knowledge of global regulatory practices, electronic submission guidelines and requirements
• Communicates questions and issues as they arise with possible solutions
• Supports other functions as appropriate
• Participates in submission team meetings
• Effective written and verbal communication skills
• Works with supervision
• Ability to prioritize and strong attention to detail
• Comfortable working with electronic docbases, databases, publishing systems, and eCTD viewers; technically savvy with Veeva Vault RIM, Lorenz Docubridge, Microsoft Office, and web-based applications

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail] . Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection . Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1606855 : Submission Senior Specialist Experience Level Senior Level