Bristol Myers Squibb
ManagerI,EULabelingManagement
“Manager I, EU Labeling Management at Bristol Myers Squibb. Skills: EU Labelling process oversight, Project management, Regulatory submissions, Artwork creation. Provide EU Labelling process oversight. Manage labelling submission planning”
What You'll Achieve.
Ensure timely regulatory submissions/approvals; Ensure timely availability of updated artworks and EMA Certificates; Minimize the risk and associated costs to BMS and patients of a significant error occurring in final labelling preparations
Industry & Context.
Participates in solutions development to challenging areas
What They're Looking For.
Must Have
Excellent command of language (English), Direct regulatory or labelling experience in a regulated environment, 3 years’ experience in Pharmaceutical industry
Nice to Have
Solid knowledge of medical and scientific terminology, Solid knowledge of biopharma manufacturing complexities, Solid understanding of EMA Regulatory and Labelling regulations and standards, Knowledge/ understanding of another language in the region supported
What You'll Do.
Provide EU Labelling process oversight
Manage labelling submission planning
Manage post-approval activities
Prepare labelling documents for submissions
Coordinate artwork creation
Support ERPSs for labelling activities
Coordinate external requests for data
Distribute EU labelling submission documents
Oversee EU Labelling operational activities
Liaise with Readability Testing company
Ensure high quality and accuracy of labelling
Coordinate translation of Product Information
Coordinate translation
submission to Member States
Perform quality control of language PIs
Gather information for printed packaging components
and track artwork updates
Coordinate and complete Artwork Requests
Interact with Local Regulatory
Supply Chain and manufacturing operations sites
Comply with the EU end-to-end labelling process
Elevate risks and issues
Participate in solutions development
How You'll Work.
Team & Collaboration
Work as part of a team that supports global functions; Interact with Local Regulatory, Artwork teams, Supply Chain and manufacturing operations sites
Communication Scope
Good communication skills; Communicating impact on BMS business and products; Professionalism
Process & Methodology
Project management, Manage labelling submission planning, Manage post-approval activities, Oversee EU Labelling operational activities, Initiate, coordinate, and track artwork updates, Coordinate and complete Artwork Requests and Implementation Plans, Elevate risks and issues, Participate in solutions development
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