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 compelling 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 Responsibilities The Senior Specialist manages and coordinates the timely compliant and accurate delivery of submission documents and dossiers to health authorities Tracks collects and reviews all components for submission to Health Authorities Interacts with responsible parties for quality submission documents for submissions Facilitate submission team meetings with team support May participate in focused projects related to their scope of work Prepare Cover Letter FDA Forms and submission content plan for Investigational Marketed Applications submissions CSR Variations DSURs PSURs Initial IND Submission Attend Submission Team and kick off meetings represent RISM and drive submission publishing timelines Coordinate Initial IND Kick off meeting submission Coordinate IND NDA BLA and Orphan Drug Annual Reports Develop Update job aid documents for departmental process Build Manage CARA PRISM Structures for Global CMC Submissions CMC Submission Specialist Coordinate non-eCTD submissions with International Regulatory Team lead Experience Key Competency Requirements 3 years relevant submissions experience Foundational knowledg