Global Submissions Specialist (IND/eCTD) – Hybrid

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

Job summary

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.

Qualifications

• 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

Responsibilities

• 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

Skills

Regulatory submissions

Stakeholder management

Project coordination

Attention to detail

Education

Bachelor's degree in science or related field

Tools

Veeva RIM

Lorenze docuBridge

Job description

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.