Senior Manager, Global Labeling Strategy

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

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

The Senior Manager, Global Labeling Strategy - based in Warsaw - 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]).

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;
• 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 (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.

Key Competency Requirements

• 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 Candidates Would Also Have

• 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.

#LI-Hybrid

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

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.

Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of pa