Manager I, Global Submission Management - CMC

Bristol-Myers Squibb Co; Warszawa; On-site; PLN 175,000 - 212,000; Full time

Job summary

Bristol Myers Squibb in Warsaw, Poland is seeking a Manager I, Global Submission Management – CMC to lead end-to-end regulatory submissions for INDs, CTAs, and marketing applications, coordinating with CMC, Manufacturing, Quality, and Regulatory teams.

The role emphasizes eCTD strategy, publishing in Veeva RIM, and ensuring timely delivery to Health Authorities, with opportunities to drive process improvements and global alignment.

Qualifications

• BA/BS degree, science/technology field preferred.
• 5+ years relevant submissions experience.
• Proficient knowledge of global regulatory practices, submission guidelines, and requirements.
• Strong analytical and communication skills in English.

Responsibilities

• Define eCTD submission strategies and document requirements.
• Drive execution of Global Submission Plan and track components.
• Publish submissions in eCTD system for HA delivery.
• Lead regulatory meetings and drive timelines.
• Coordinate CMC content for global regulatory submissions.

Skills

Regulatory submissions

eCTD publishing

Veeva RIM

Project management

Cross-functional collaboration

Regulatory knowledge (FDA/EMA/HC)

English communication

Education

BA/BS degree in science/tech

Tools

Veeva RIM

eCTD system

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.

Position Summary

The Manager, Submission Management supports end-to-end regulatory activities for assigned projects, including leading the preparation, compilation, and delivery of compliant US IND, CTA, and marketing application submissions for global health authorities. The role partners closely with Regulatory CMC, Technical Operations, Quality, Manufacturing, and Supply Chain functions to ensure timely development and submission of CMC regulatory content throughout the product lifecycle while supporting continuous improvement initiatives.

Key Responsibilities:

· 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 available tools to generate reports and track submission content.

· Coordinate non-eCTD submissions with international teams.

· Partner with Regulatory CMC, Manufacturing, Quality, Analytical Development, and Technical Operations teams to plan, coordinate, and track CMC documentation required for global regulatory submissions and health authority interactions.

· Manage the submission readiness of CMC content for INDs, IMPDs, BLAs, NDAs, MAAs, lifecycle management submissions, variations, supplements, and responses to health authority questions.

· Ensure CMC submission components are complete, compliant, and aligned with current global regulatory requirements and company standards.

· Support regulatory assessment of manufacturing changes, process improvements, site transfers, specification updates, and other post-approval CMC changes impacting global submissions.

· Coordinate CMC contribution to health authority requests, deficiency responses, inspections, and agency meeting packages.

Continuous Improvement Initiatives

· Drive initiatives that promote innovation and simplify processes to enhance efficiencies 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.

· Drive harmonization and standardization of CMC submission planning, content management, and regulatory processes across programs and regions.

· Support implementation and optimization of regulatory technologies, data standards, and digital solutions that improve CMC submission management and compliance.

Experience and skills required:

· BA/BS degree, science/technology field preferred.

· 5+ years relevant submissions experience.

· 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 intelligence and automation tools.

· Experience supporting Regulatory CMC activities and managing CMC submission components for development and/or commercial products.

· Understanding of pharmaceutical and/or biologics manufacturing processes, quality systems, lifecycle management, and global CMC regulatory requirements.

· Experience with Module 3 content, CMC document management, and lifecycle submissions in major markets (FDA, EMA, PMDA, Health Canada, and other global health authorities) is preferred.

· Knowledge of manufacturing change management and regulatory impact assessments is highly desirable.

#LI-Hybrid

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

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