Senior Manager 1, Submission Management

Bristol Myers Squibb EU Policy; Warszawa; Hybrid; PLN 251,000 - 304,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible work options

Global collaboration

Job summary

Bristol Myers Squibb in Warsaw is seeking a Senior Manager - Submission Management to lead end-to-end regulatory submissions for global health authorities and contribute to continuous improvement.

Based in Poland, the role will guide IND and marketing submissions, manage a team, and collaborate with global colleagues to ensure timely, compliant documents. Strong regulatory knowledge and leadership required.

Qualifications

• BA/BS degree in science or technology field preferred.
• 7+ years of submissions experience and people management experience.
• Strong knowledge of global regulatory practices and submission guidelines.
• Excellent English communication and ability to present complex topics.

Responsibilities

• Define IND and marketing submission strategies and requirements.
• Prepare and deliver eCTD submission dossiers for global markets.
• Lead Global Submission Plan execution and monitor progress for timely health authority submissions.
• Manage submission production activities including lifecycle management submissions.
• Provide training and mentoring to the team and collaborate with cross-functional partners.

Skills

Regulatory submissions

Team leadership

Stakeholder collaboration

Project management

English communication

Education

BA/BS degree in science/tech

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.

Shape the Future of Clinical Trials with Us

Join Our Global Development Team!

Are you ready to support the BMS portfolio and sets the strategic business direction? We’re seeking a passionate and experienced Senior Manager - Submission Management to support end-to-end regulatory activities for assigned projects, including leading the preparation and compilation of compliant US IND and marketing submissions for global health authorities and supporting continuous improvement initiatives. Position office based in Poland - Warsaw.

Position Responsibilities

Regulatory Strategy & Submission

• Collaborate with key stakeholders to define IND and marketing submission strategies and document requirements, ensuring alignment with regulatory standards and project timelines.
• Assess core submission deliverables to ensure compliance, prepare and deliver eCTD submission dossiers for global markets.
• Drive the execution of the Global Submission Plan for assigned products, collaborating with global teams and proactively monitoring progress to ensure timely health authority submissions.
• Manage the submission production activities for assigned products including the lifecycle management of applications.
• Manage the submission production activities for queries, commitments, and other lifecycle management submissions with health authorities.

Continuous Improvement Initiatives

• Drive initiatives that promote innovation and simplify processes to enhance efficiencies for BMS teams.
• Contribute to the ongoing maintenance of regulatory requirements to ensure accurate and current regulatory information.
• Ensure consistency of 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.

Team Leadership

• Lead a team of direct reports managing resource and allocation and assigned projects, provide training and mentoring to new staff, and support team with development and innovation.

Education & Experience Requirements

• BA/BS degree, science / technology field preferred.
• 7+ years relevant submissions experience and people management experience.

Key Competency Requirements

• Proficient knowledge of global regulatory practices, submission guidelines and requirements.
• Collaborates with key stakeholders and resolves cross-functional issues independently and generates solutions by weighing risks and dependencies.
• Support of other RISM members sharing expertise, providing guidance and serving as a SME.
• Communicates effectively in English and simplifies complex topics for presentations and workshops.
• Applies project management methodologies and strategic thinking to define objectives, track progress, and deliver results on increasingly more complex projects.
• Proficient with desktop software and able to instruct others.

Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned.

Why Join Us?

• Be a key leader in global studies impacting diverse therapeutic areas.
• Work with talented teams across the US, India, Switzerland, and beyond.
• Grow your career in a supportive, forward-thinking environment.
• Make your mark in delivering high-quality, innovative clinical solutions.

Compensation Overview

Warsaw - PL: zł251,100 - zł304,272

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.

R1605868 : Senior Manager 1, Submission Management

Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs.

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.