Manager, Submission Management

Bristol-Myers Squibb Co; Warszawa; Hybrid; PLN 163,000 - 197,000; Full time

Benefits offered by this job

Incentives and stock opportunities

Job summary

Bristol Myers Squibb in Warsaw, Poland seeks a Senior Manager - Submission Management for Clinical Trials to lead end-to-end regulatory submissions across global health authorities. You will collaborate with multinational teams, drive submission strategies, and oversee data required for EU CTIS and substantial modifications.

The role requires BA/BS in science, 7+ years of regulatory submissions experience and people management, with strong English communication.

Qualifications

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

Responsibilities

• Define clinical trial submission strategies and document requirements with stakeholders.
• Prepare and distribute global CTA dossiers and manage data required for EU CTIS and substantial modifications.
• Monitor regulatory assessment, negotiate with stakeholders, and respond to information requests.
• Track queries and submissions with health authorities and provide periodic status updates on commitments.
• Drive continuous improvement initiatives and maintain regulatory information to ensure accuracy.
• Lead a team of direct reports, manage resource allocation, and mentor staff.

Skills

Regulatory submissions

Leadership

Cross-functional collaboration

Regulatory affairs knowledge

Project management

Education

BA/BS in science or technology

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 - Clinical Trials to support end-to-end regulatory activities for assigned projects, including leading the preparation and compilation of compliant clinical trial submissions for global health authorities and supporting continuous improvement initiatives. Position office based in Poland - Warsaw.

Position Responsibilities:

• Collaborate with global and local stakeholders to define clinical trial submission strategies and document requirements, ensuring alignment with regulatory standards and project timelines.
• Assess core submission deliverables to ensure compliance, prepare and distribute global CTA dossiers, and manage data required for EU CTIS and substantial modifications.
• Monitor and influence the regulatory assessment process, drive negotiations with stakeholders to resolve information requests, and communicate regulatory changes to ensure ongoing compliance.
• Manage and track queries, commitments, and submissions with health authorities, collaborate with subject matter experts for responses, and provide periodic status updates on commitments.
• 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 Clinical Trial 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

• Degree Requirements BA/BS degree, science / technology field preferred.
• 7+ years relevant regulatory 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.

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.

Compensation Overview:

Warsaw - PL: zł162,775 - zł197,245 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. 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.

• Additional incentive cash and stock opportunities (based on eligibility) may be available.

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.

R1601388 : Manager, Submission Management 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.