Submission Manager

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.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more : .

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 Submission Manager 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?

Ready to take your leadership to the next level? Apply now and help us shape the next generation of Submissions Manager - Clinical Trials

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.

LI-Hybrid

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role :

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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 :

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