Senior Specialist, Submission Management

Bristol-Myers Squibb Co; Warszawa; Hybrid; PLN 117.000 - 141.000; Vollzeit

Zusammenfassung

Bristol Myers Squibb in Warsaw, Poland offers a hybrid role for a Senior Specialist, Submission Management, focused on IND and global regulatory submissions. You will own end-to-end submissions and collaborate with global teams to ensure high-quality dossiers reach health authorities on time.

Ideal candidates have 1–3+ years in regulatory submissions and familiarity with eCTD, Veeva RIM, and Lorenz docuBridge.

Qualifikationen

• Bachelor’s degree (science or related field)
• 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

Aufgaben

• Lead 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

Kenntnisse

Regulatory submissions

Stakeholder management

Project coordination

Attention to detail

Ausbildung

Bachelor's degree in science or related field

Tools

Veeva RIM

Lorenze docuBridge

Jobbeschreibung

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.

Shape How Medicines Reach Patients Worldwide

The Opportunity

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

What You’ll Do

• 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

Compensation Overview

Warsaw - PL: zł116,650 - zł141,347 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.

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.

R1601389 : Senior Specialist, Submission Management Data Privacy Link We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.