Global Regulatory Submissions Lead (Hybrid)

Bristol-Myers Squibb Co; Województwo mazowieckie; Hybrid; PLN 144,000 - 175,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

Bristol Myers Squibb in Warsaw is seeking a Senior Specialist, Submission Management to own end-to-end IND and global regulatory submissions, ensuring compliant, high-quality dossiers reach health authorities on time and driving consistency across teams.

You will coordinate cross-functional submissions, manage timelines and risks, oversee eCTD publishing, and utilize Veeva RIM and Lorenz docuBridge to monitor content and reporting across regions.

Qualifications

• Bachelor’s degree in science or related field is preferred.
• 1–3+ years experience in regulatory submissions is typical.
• Strong communication and stakeholder engagement skills are expected.

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 relevant systems.
• Coordinate non-eCTD submissions with international teams.

Skills

Regulatory submissions

Cross-functional coordination

Global collaboration

Stakeholder management

Education

Bachelor’s degree (science or related field preferred)

Tools

Veeva RIM

Lorenz docuBridge

eCTD publishing

Job description

Bristol Myers Squibb in Warsaw is seeking a Senior Specialist, Submission Management to own end-to-end IND and global regulatory submissions, ensuring compliant, high-quality dossiers reach health authorities on time and driving consistency across teams.

You will coordinate cross-functional submissions, manage timelines and risks, oversee eCTD publishing, and utilize Veeva RIM and Lorenz docuBridge to monitor content and reporting across regions.