Global Regulatory Submissions Manager

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

Job summary

Bristol Myers Squibb in Warsaw is seeking a Manager I, Global Submission Management (CMC) to lead end-to-end regulatory submissions and ensure compliantIND/marketing submissions for global health authorities. You will guide eCTD strategies, coordinate cross-functional teams, and optimize processes to support regulatory excellence.

Minimum 5+ years in submissions, a BA/BS in a science/tech field, and strong English communication are required.

Qualifications

• BA/BS degree in science/technology
• 5+ years of submissions experience
• Fluent English communication (written and spoken)

Responsibilities

• Define eCTD submission strategies with stakeholders.
• Drive the execution of the Global Submission Plan.
• Track submission components and manage risks and timelines.
• Publish submissions in the eCTD system for HA portals.
• Lead regulatory meetings and maintain process documentation.

Skills

Regulatory knowledge

Project management

English communication

Stakeholder collaboration

Analytical thinking

Education

BA/BS in science or technology

Tools

Veeva RIM

eCTD publishing

Job description

Bristol Myers Squibb in Warsaw is seeking a Manager I, Global Submission Management (CMC) to lead end-to-end regulatory submissions and ensure compliantIND/marketing submissions for global health authorities. You will guide eCTD strategies, coordinate cross-functional teams, and optimize processes to support regulatory excellence.

Minimum 5+ years in submissions, a BA/BS in a science/tech field, and strong English communication are required.