Senior Specialist, 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 SummaryManagement supports end-to-end regulatory activities for assigned projects, including executing the preparation and compilation of compliant US IND and marketing maintenance submissions for global health authorities.Position ResponsibilitiesCollaborate with stakeholders to define eCTD submission strategies and document requirements, ensuring alignment with regulatory standards and project timelines.Collaborate with teams to execute the Global Submission Plan.Track and ensure timely progress of submission components to Health Authorities.Execute submission management and publishing activities in the eCTD publishing tool for efficient eCTD production and delivery through HA portals.Represent team in regulatory/submission meetings driving deliverable and publishing timelines.Participate in department initiatives within scope.Execute required activities in RIM systems (Veeva RIM) and use available tools to generate reports and track submission content.Coordinate non-eCTD submissions with international teams.Continuous Improvement InitiativesSupport 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.RequirementsRequired degrees, certifications, and/or licensure relevant to role. BA/BS degree, science / technology field preferredMinimum number of years of relevant experience expected. 1+ years relevant submissions experienceFoundational knowledge of global regulatory practices, submission guidelines, and requirementsStrong critical thinking and problem-solving skills; proposes alternative solutions for submission-related and project situationsEffective stakeholder engagement and communication, including proficiency in English (written and oral) and ability to communicate with non-English speakers.Ability to execute and prioritize non-complex projects with attention to detail; communicates project status and updates to relevant stakeholdersDemonstrates basic presentation skills and adapts content for diverse audiencesProficiency with desktop software and regulatory systems with the ability to instruct others; understand how non-regulatory systems interact with regulatory systems. Embrace the use of artificial intelligence and automation tools.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.Ready to take your leadership to the next level? Apply now and help us shape the next generation of Submissions Specialists.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-HybridIf 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: zł116,650 - zł141,347 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 faci