Manager I, Global Submission Management CMC

At Bristol Myers Squibb our employees often ask Who are you working fora 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.

Position Summary Should be pulled from the appropriate Job Description data in Workday appropriate source per department or a contractor top-line sentences in plain text focused on key accountabilities or no more than 75 words. Avoid internal jargon or acronyms. The 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 ResponsibilitiesShould be pulled from the appropriate Job Description data in Workday appropriate source per department or a contractor 5-9 bullet points; each describing a distinct and primary responsibility of the role. Avoid generic comments such as works well with others (IND and Marketing) Submission ManagementCollaborate with stakeholders to define eCTD submission strategies and document requirements ensuring alignment with regulatory standards and project 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 required activities in RIM systems (Veeva RIM) and use availabile tools to generate reports and track submission content. Coordinate non-eCTD submissions with international Improvement InitiativesDrive initiatives that promote innovation and simplify processes to enhance efficienices 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 RequirementsRequired degrees certifications and/or licensure relevant to degree science / technology field preferredExperience RequirementsMinimum number of years of relevant experience expected.5 years relevant submissions experienceKey Competency RequirementsProficient knowledge of global regulatory practices submission guidelines and requirements; able to identify and resolve issues with support from senior team members Strong 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 delivery Advanced 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 inteligence and automation tools.

We hire for skills and capabilities not just credentials if this role excites you but doesnt perfectly match your resume we encourage you to apply anyway.

Warsaw - PL: zł174980 - zł212026

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 employees 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.

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