Manager, Submission Management

Working with Us
Challenging. Meaningful. Life-changing.

Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.

From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

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.

Why Join Us?

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 kindly ask all applicants to send their CV in English.