Global Labeling Strategy Lead – Lifecycle & Submissions

Bristol-Myers Squibb; Poland; Hybrid; PLN 230,000 - 279,000; Full time

Job summary

Bristol Myers Squibb is seeking a Senior Manager, Global Labeling Strategy, based in Warsaw. You will lead labeling strategy for CCDS, USPI, and SmPC across lifecycle projects, coordinating with global teams to ensure timely and compliant submissions.

The role emphasizes collaboration across regulatory, safety, clinical development and medical teams, ensuring high-quality labeling and effective cross-functional planning in a hybrid work setting.

Qualifications

• Masters of Life Sciences or equivalent, with thorough understanding of scientific principles or Bachelor of Lifesciences with at least 2 years of Regulatory and / or Regulatory Labeling Experience.

Responsibilities

• Drives labeling strategy in partnership with the Global Regulatory Leader for CCDS, USPI and SmPC.
• Serves as the primary contact for the Labeling Strategy Team (LST).
• Works with Global Regulatory Strategy, WWPS, Clinical Development and Medical teams with LST.
• Coordinates labeling activities of contributors, reviewers and approvers.
• Manages the label review and approval process to maximize speed and quality.
• Ensures effective planning of cross-functional labeling activities.
• Supports labeling-related inquiries from Health Authorities and inspections.
• Reviews country labels to ensure labeling compliance.
• Participates in initiatives to improve processes and tools for global label development.

Education

Masters of Life Sciences or equivalent

Bachelor of Lifesciences

Job description

Bristol Myers Squibb is seeking a Senior Manager, Global Labeling Strategy, based in Warsaw. You will lead labeling strategy for CCDS, USPI, and SmPC across lifecycle projects, coordinating with global teams to ensure timely and compliant submissions.

The role emphasizes collaboration across regulatory, safety, clinical development and medical teams, ensuring high-quality labeling and effective cross-functional planning in a hybrid work setting.