Senior Manager 1, Submission Management

Bristol-Myers Squibb; Poland; On-site; PLN 251,000 - 304,000; Full time

Job summary

Bristol Myers Squibb in Warsaw, Poland, is seeking a Senior Manager - Submission Management to support end-to-end regulatory activities and lead the preparation of compliant US IND and global submissions.

You will collaborate with global teams, define submission strategies, manage production and lifecycle submissions, and mentor a team while driving continuous improvement in regulatory processes. This role offers hybrid work with up to 50% remote.

Qualifications

• Bachelor's degree in science/technology field.
• 7+ years of submissions experience and people management.
• Proficient knowledge of regulatory practices and submission guidelines.

Responsibilities

• Define IND and marketing submission strategies and document requirements.
• Prepare and deliver eCTD submission dossiers for global markets.
• Lead the Global Submission Plan and monitor progress.
• Manage the submission production activities and lifecycle submissions.
• Mentor team and drive process improvements across regulatory functions.

Skills

Regulatory submissions

Leadership

Project management

English communication

eCTD knowledge

Education

BA/BS degree in science or technology

Tools

eCTD 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 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:

• 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.


• 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.


• 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.

Remote Work Details

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: 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,