Global Labeling Strategy Lead

Biopharma Careers; Warszawa; Hybrid; PLN 230,000 - 279,000; Full time

Job summary

Bristol Myers Squibb in Warsaw is seeking a Senior Manager, Global Labeling Strategy to lead labeling updates for CCDS, USPI and SmPC across lifecycle projects. The role requires a life sciences master's or equivalent with regulatory labeling experience; you will partner with Global Regulatory Strategy, WWPS, Clinical Development and Medical teams in a hybrid work environment in Warsaw.

You will coordinate cross-functional labeling activities, ensure compliance with global regulations, and

Qualifications

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

Responsibilities

• Drives labeling strategy in partnership with the Global Regulatory Leader (GRL) in line with the overall regulatory strategy by providing labeling expertise for CCDS, USPI and SmPC for low to medium complex projects, mainly at a Lifecycle Management (LCM) stage.
• Serves as primary contact for Labeling Strategy Team (LST).
• Works closely with counterparts in Global Regulatory Strategy, Worldwide Patient Safety (WWPS), Clinical Development and Medical with LST, under management supervision.
• Serves as interface for Country Regulatory Managers to support timely and quality labeling submissions globally.
• Coordinates labeling activities of multifunctional contributors, reviewers and approvers as well as manages the label review and approval process to maximize speed and quality.
• Ensures effective planning of all cross-functional labeling activities.
• Support responses to labelling-related inquiries from Health Authorities and related to inspection activities.
• Reviews country labels to ensure labeling compliance.
• Participates in key initiatives to support efficient global label development and timely worldwide submissions and approvals.

Skills

Labeling strategy

Regulatory knowledge

Cross-functional collaboration

Project management

Communication skills

Education

Master's degree in Life Sciences

Bachelor of Life Sciences with regulatory labeling experience

Job description

Bristol Myers Squibb in Warsaw is seeking a Senior Manager, Global Labeling Strategy to lead labeling updates for CCDS, USPI and SmPC across lifecycle projects. The role requires a life sciences master's or equivalent with regulatory labeling experience; you will partner with Global Regulatory Strategy, WWPS, Clinical Development and Medical teams in a hybrid work environment in Warsaw.

You will coordinate cross-functional labeling activities, ensure compliance with global regulations, and