Global Submissions Lead — Hybrid Remote

Bristol Myers Squibb; Warszawa; Hybrid; PLN 117,000 - 141,000; Full time

Job summary

Bristol Myers Squibb in Warsaw is seeking a Senior Specialist to own end-to-end regulatory submissions (IND and global) and drive high-quality dossiers to health authorities. You will collaborate across global teams, define submission strategies, and ensure on-time delivery while promoting operational excellence.

The role offers hybrid work with up to 50% remote and exposure to diverse regulatory programs across regions and therapeutic areas.

Qualifications

• Bachelor’s degree in science or related field.
• 1–3+ years experience in regulatory submissions.
• Understanding of global regulatory requirements and submissions.
• Exposure to IND, eCTD, or global submissions.
• Familiarity with Veeva RIM and LorenzedocuBridge publishing tools a plus.
• Strong communication and stakeholder engagement skills.
• Ability to manage priorities and deliver against timelines.

Responsibilities

• Lead end-to-end submission management (IND and global).
• Collaborate with cross-functional and global stakeholders.
• Manage timelines, risks, and dependencies across submissions.
• Execute and oversee eCTD publishing activities.
• Maintain submission data and reporting in Veeva RIM.
• Coordinate non-eCTD submissions with international teams.
• Ensure consistency across submissions, studies, and regions.
• Contribute to process improvements and innovation.

Skills

Regulatory submissions

Global regulatory knowledge

IND/eCTD submissions

Veeva RIM

LorenzedocuBridge

Stakeholder engagement

Prioritization

Education

Bachelor’s degree (science or related field preferred)

Tools

Veeva RIM

LorenzedocuBridge publishing tool

Job description

Bristol Myers Squibb in Warsaw is seeking a Senior Specialist to own end-to-end regulatory submissions (IND and global) and drive high-quality dossiers to health authorities. You will collaborate across global teams, define submission strategies, and ensure on-time delivery while promoting operational excellence.

The role offers hybrid work with up to 50% remote and exposure to diverse regulatory programs across regions and therapeutic areas.