Senior Manager, Global Labeling Strategy

Senior Manager, Global Labeling Strategy

Position Summary

The Senior Manager, Global Labeling Strategy, has overall accountability for relevant updates to labeling documents (e.g. Company Core Data Sheets [CCDS], United States Package Inserts [USPI] and EU Summary of Product Characteristics [SmPC]).

Position Responsibilities

• Drives labeling strategy in partnership with the Global Regulatory Leader (GRL) in line with the overall regulatory strategy by providing labeling expertise (labeling regulations, internal processes, and competitor analyses) 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;
• Supports responses to labeling‑related inquiries from Health Authorities and related to inspection activities;
• Reviews country labels to ensure labeling compliance;
• Participates in key initiatives (process improvements, development of new tools and technologies) to support efficient global label development and timely worldwide submissions and approvals.

Required Experience and 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.
• Ability to understand regulatory implications of product strategy related to labeling development, assessment, and management;
• Ability to develop strong and positive working relationships across diverse teams and within a global environment;
• Ability to influence and lead a diverse group of Subject Matter Experts from a variety of disciplines and facilitate discussions and decision making;
• Experience in managing low-to-medium complex projects;
• Excellent verbal and written communication skills;
• Keen attention to detail and accuracy;
• Ability to assimilate clinical and scientific information and present it in a concise manner;
• Ability to think creatively and good problem‑solving skills.

Ideal Candidate Additional Qualifications

• Basic knowledge of regulatory labeling and labeling processes;
• Have labeling experience in at least one major region and CCDS;
• Have a basic knowledge of procedures, regulatory requirements and GxP;
• Good understanding of Drug Development and Commercialization of prescription medicines.

Compensation Overview

Warsaw - PL: zł230,270 - zł279,037

The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job‑related knowledge, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Supporting People with Disabilities: BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer if needed.