Manager I, Global Submission Management

Working with UsChallenging. 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: careers.bms.com/working-with-us.Position SummaryThe Manager, Submission Management supports end-to-end regulatory activities for assigned projects, including leading the preparation and compilation of compliant US IND and marketing complex submissions for global health authorities and supporting continuous improvement initiatives.Position ResponsibilitiesCollaborate with stakeholders to define eCTD submission strategies and document requirements, ensuring alignment with regulatory standards and project timelines.Collaborate with teams to drive the execution of the Global Submission Plan.Track and ensure timely progress of submission components to Health Authorities. Apply risk and critical path management practices.Execute submission management and publishing activities in the eCTD publishing system for efficient eCTD production and delivery to HA portals.Lead/represent team in regulatory/submission meetings driving deliverable and publishing timelines.Lead/participate in department initiatives within scope. Develop/update procedural documentation as needed.Execute required activities in RIM systems (Veeva RIM) and use availabile tools to generate reports and track submission content.Coordinate non-eCTD submissions with international teams.Continuous Improvement InitiativesDrive initiatives that promote innovation and simplify processes to enhance efficiencies for BMS teams.Lead the ongoing maintenance of regulatory requirements to ensure accurate and current regulatory information.Ensure cross functional alignment for 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.RequirementsBA/BS degree, science / technology field preferredMinimum number of years of relevant experience expected. 5+ years relevant submissions experienceProficient knowledge of global regulatory practices, submission guidelines, and requirements; able to identify and resolve issues with support from senior team membersStrong analytical and critical thinking skills for solution development, decision-making, and implementation; generates alternative solutions by weighing risks and dependenciesEffective communication skills in English (written and oral), including presenting complex information and collaborating with non-English speakersSolid project management abilities: defines objectives, sets priorities, tracks progress, manages resources, and communicates status and risks within project teamsBuilds collaborative relationships by understanding stakeholder needs, priorities, and processes; drives team communication for successful project deliveryAdvanced proficiency with desktop software and regulatory systems with the ability to instruct others; understands how non-regulatory systems interact with regulatory systems. Embrace the use of artificial intelligence and automation tools.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.Compensation Overview:Warsaw - PL: zł174,980 - zł212,026 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, and experience. The final compensation will be determined based on demonstrated experience and in accordance with pay equity principles and applicable employment laws.Uniquely Interesting Work, Life-changing CareersWith 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 ProtocolBMS 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 att