Manager, Submission Management Clinical Trials

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 Clinical Trials supports 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 ResponsibilitiesCollaborate 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.Prepare and distribute the global Clinical Trial Application dossier to country applicants and CROs for submission to ECs and HAs. Support IVDR coordination when applicable.Prepare the data required in CTIS for CTA dossiers and their subsequent substantial modifications.Execute required activities in RIM systems (Veeva RIM) and use availabile tools to generate reports and track submission content.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 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.RequirementsRequired degrees, certifications, and/or licensure relevant to role. BA/BS degree, science / technology field preferredMinimum number of years of relevant experience expected. 3+ years relevant regulatory 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 f