Manager, Submission Management

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

Benefits offered by this job

Remote work up to 50%

Job summary

Bristol Myers Squibb is seeking a Senior Manager - Submission Management - Clinical Trials to lead end-to-end regulatory activities for assigned projects in Warsaw, Poland. The role focuses on preparing compliant clinical trial submissions for global health authorities and driving continuous improvement initiatives, with office-based work in Poland - Warsaw, and up to 50% remote collaboration.

Ideal candidates will have BA/BS in a science/tech field, 7+ years in regulatory submissions, and

Qualifications

• BA/BS degree in science or technology field.
• 7+ years of regulatory submissions experience and people management.
• Proficient knowledge of global regulatory practices and submission guidelines.

Responsibilities

• Define submission strategies with global and local stakeholders to meet timelines.
• Prepare and manage dossiers, EU CTIS data, and respond to information requests.
• Drive process improvements and maintain current regulatory information.
• Lead and mentor team members, allocate resources and oversee projects.

Skills

Regulatory submissions

People management

English communication

Project management

Regulatory practices

Desktop software

Education

BA/BS degree in science/technology

Tools

Desktop software

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:

• Regulatory Strategy & Submission
  • 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.

#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: zł162,775 - zł197,245

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 s