Global Submissions Lead - Hybrid/Remote 50%

Bristol Myers Squibb

Warszawa

Hybrid

PLN 116,650 - 141,347

Full time

14 days+
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Job summary

Bristol Myers Squibb in Warsaw, Poland, is seeking a Senior Specialist, Submission Management to lead end-to-end IND and global regulatory submissions.

You will coordinate global teams, define strategy and timelines, oversee eCTD publishing, and maintain submission data in Veeva RIM, contributing to the efficiency and quality of health authority dossiers.

The role offers hybrid work with up to 50% remote and opportunities to shape submissions across regions.

Qualifications

  • Bachelor’s degree in science or related field preferred.
  • 1–3+ years of regulatory submissions experience.
  • Experience with IND, eCTD, or global submissions.
  • Familiarity with Veeva RIM and Lorenz docuBridge publishing tool is a plus.
  • Strong communication and stakeholder engagement skills.

Responsibilities

  • Lead end-to-end IND and global submission management.
  • Collaborate with cross-functional and global teams to deliver compliant dossiers.
  • Define submission strategy, timelines, and risks.
  • Oversee eCTD publishing and content management.
  • Maintain submission data and reporting in Veeva RIM.
  • Coordinate non‑eCTD submissions with international teams.
  • Ensure consistency across submissions, studies, and regions.
  • Support process improvements and automation initiatives.

Skills

Submission management
Regulatory submissions
IND and global submissions
Veeva RIM
Cross-functional collaboration

Education

Bachelor’s degree (science or related field)

Tools

Lorenz docuBridge
eCTD publishing

Job description

Bristol Myers Squibb in Warsaw, Poland, is seeking a Senior Specialist, Submission Management to lead end-to-end IND and global regulatory submissions.

You will coordinate global teams, define strategy and timelines, oversee eCTD publishing, and maintain submission data in Veeva RIM, contributing to the efficiency and quality of health authority dossiers.

The role offers hybrid work with up to 50% remote and opportunities to shape submissions across regions.

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