Senior Specialist, Submission Management

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 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.

Requirements

• Collaborate 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.

Benefits

• Competitive salary
• Additional incentive cash and stock opportunities