Senior Specialist, Submission Management

About the role

What if your work didn't just support submissions... but helped accelerate how innovative therapies reach patients across the globe? At Bristol Myers Squibb, we're transforming how regulatory submissions are delivered-making them faster, smarter, and globally aligned. As a Senior Specialist , you'll play a critical role in driving high-quality submissions and improving how teams operate together globally. Your Mission Own and deliver IND and global regulatory submissions end-to-end, ensuring compliant, high-quality dossiers reach health authorities on time-while driving consistency, efficiency, and operational excellence across submission activities. What Your Week Might Look Like Leading coordination of submission activities across global teams Partnering with stakeholders to define submission strategy and timelines Managing IND and marketing application submissions from planning through to delivery Tracking progress, identifying risks, and ensuring milestones stay on track Executing eCTD publishing and managing submissions via HA portals Working in Veeva RIM and Lorenz docubridge publishing tool to monitor , report, and manage content

Responsibilities

• Drive end-to-end submission management (IND and global applications)
• Collaborate with cross-functional and global stakeholders to deliver compliant dossiers
• Manage timelines, risks, and dependencies across submission projects
• Execute and oversee eCTD publishing activities
• Maintain submission data, reporting, and tracking in Veeva RIM
• Coordinate non-eCTD submissions with international teams
• Ensure consistency across submissions, studies, and regions
• Contribute to continuous improvement and innovation initiatives
• You'll Thrive If You
• Take ownership and proactively drive deliverables
• Enjoy balancing coordination, execution, and problem-solving
• Are confident working across global, matrixed environments
• Have strong attention to detail and organisational skills
• Are motivated to improve processes and embrace digital tools and automation
• Your Background
• Bachelor's degree (science or related field preferred)
• Experience in regulatory submissions (typically 1-3+ years)
• Understanding of global regulatory requirements and submission processes
• Exposure to IND, eCTD, or global submissions
• Familiarity with tools such as Veeva RIM and Lorenze docuBridge publishing tool is a plus
• Strong communication and stakeholder engagement skills
• Ability to manage priorities and deliver against timelines
• Why This Role is Different
• Meaningful exposure to global regulatory submissions and health authorities
• Opportunity to work across multiple regions and therapeutic areas
• Strong visibility within regulatory and cross-functional teams
• A chance to improve how submissions are delivered-at scale and with impact
• Flexibility
• Hybrid role with the option to work remotely up to 50% of the time , aligned with business and collaboration needs.
• #LI-Hybrid
• If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
• Compensation Overview:
• Warsaw - PL: zł116,650 - zł141,347
• Uniquely Interesting Work, Life-changing Careers
• With a single vision as inspiring as "Transforming patients' lives through science™ ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual t

Benefits

Additional Information

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Shape How Medicines Reach Patients Worldwide

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