Global Regulatory Submissions Lead

Bristol-Myers Squibb; Poland; On-site; PLN 175,000 - 212,000; Full time

Job summary

Bristol Myers Squibb in Warsaw, Poland seeks a Regulatory Submissions Manager to lead end-to-end regulatory submissions, including US INDs and global filings, coordinating with cross-functional teams to ensure compliance and timely delivery.

The role emphasizes collaboration on submission strategies, tracking progress with Health Authorities, and advancing continuous improvement through AI-enabled tooling and efficient publishing workflows.

Qualifications

• 5+ years relevant submissions experience.
• Proficient knowledge of global regulatory practices and guidelines.
• Strong analytical and critical thinking for solution development.
• Excellent English communication (written and oral).
• Solid project management: objectives, priorities, tracking, risks.

Responsibilities

• Collaborate with stakeholders to define eCTD submission strategies and document requirements.
• Collaborate with teams to drive the execution of the Global Submission Plan.
• Track and ensure timely progress of submission components to Health Authorities.
• Execute submission management and publishing activities in the eCTD publishing system.
• Lead/regulate team in regulatory meetings driving timelines.
• Develop/update procedural documentation.
• Execute activities in RIM systems (Veeva RIM) and generate reports.
• Coordinate non-eCTD submissions with international teams.

Skills

Regulatory submissions

Project management

Analytical thinking

English communication

Stakeholder management

Education

BA/BS degree, science / technology field preferred

Tools

Regulatory systems (RIM) - Veeva

Job description

Bristol Myers Squibb in Warsaw, Poland seeks a Regulatory Submissions Manager to lead end-to-end regulatory submissions, including US INDs and global filings, coordinating with cross-functional teams to ensure compliance and timely delivery.

The role emphasizes collaboration on submission strategies, tracking progress with Health Authorities, and advancing continuous improvement through AI-enabled tooling and efficient publishing workflows.