Manager I, Global Submission Management - CMC

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 within Regulatory IND and Marketing submissions to lead eCTD strategies, ensure timely HA submissions, and coordinate cross-functional teams.

You will drive process improvements, maintain regulatory documentation, and align IND and marketing activities across projects and countries; English communication is essential; BMS offers flexible work models and comprehensive benefits.

Qualifications

• Proven knowledge of global regulatory practices and submission guidelines.
• Excellent written and spoken English for cross-functional communication.
• Strong project management and stakeholder management abilities.

Responsibilities

• Define eCTD submission strategies and align with regulatory standards.
• Drive execution of the Global Submission Plan and track progress to Health Authorities.
• Lead submission management and publishing in the eCTD system and coordinate with international teams.
• Represent the team in regulatory meetings and maintain procedural documentation.
• Ensure compliance and drive continuous improvement within IND and marketing applications.

Skills

Regulatory practices

Submission guidelines

Communication skills

Project management

Cross-functional collaboration

Regulatory systems

AI and automation tools

Education

BA/BS degree

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?” - a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Regulatory (IND and Marketing) Submission Management

• Collaborate with stakeholders to define eCTD submission strategies and document requirements, ensuring alignment with regulatory standards and project timelines.
• Collaborate with teams to drive the execution of the Global Submission Plan.
• Track and ensure timely progress of submission components to Health Authorities. Apply risk and critical path management practices.
• Execute submission management and publishing activities in the eCTD publishing system for efficient eCTD production and delivery to HA portals.
• Lead/represent team in regulatory/submission meetings driving deliverable and publishing timelines.
• Lead/participate in department initiatives within scope. Develop/update procedural documentation as needed.
• Execute required activities in RIM systems (Veeva RIM) and use availabile tools to generate reports and track submission content.
• Coordinate non-eCTD submissions with international teams.

Continuous Improvement Initiatives

• Drive initiatives that promote innovation and simplify processes to enhance efficienices for BMS teams.
• Lead the ongoing maintenance of regulatory requirements to ensure accurate and current regulatory information.
• Ensure cross functional alignment for IND and marketing applications across projects, studies, and countries, aligning with regulatory standards and best practices.
• Effectively communicate regulatory changes to the business to maintain compliance and support continuous improvement.

Degree Requirements

BA/BS degree, science / technology field preferred

Experience Requirements

5+ years relevant submissions experience

Key Competency Requirements

• Proficient knowledge of global regulatory practices, submission guidelines, and requirements; able to identify and resolve issues with support from senior team members
• Strong analytical and critical thinking skills for solution development, decision-making, and implementation; generates alternative solutions by weighing risks and dependencies
• Effective communication skills in English (written and oral), including presenting complex information and collaborating with non-English speakers
• Solid project management abilities: defines objectives, sets priorities, tracks progress, manages resources, and communicates status and risks within project teams
• Builds collaborative relationships by understanding stakeholder needs, priorities, and processes; drives team communication for successful project delivery
• Advanced proficiency with desktop software and regulatory systems with the ability to instruct others; understands how non-regulatory systems interact with regulatory systems.
• Embrace the use of artificial inteligence and automation tools.

Compensation Overview

Warsaw - PL: zł174,980 - zł212,026

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.

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

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 you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1601849 : Manager I, Global Submission Management - CMC Data Privacy Link

We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.