Regulatory Labeling Manager – Lifecycle Products

Job Responsibilities

• Plan and lead labeling updates driven by safety changes, regulatory commitments, and periodic reviews.
• Author and revise labeling documents including the Company Core Data Sheets (CCDSs), US Prescribing Information (USPI), EU Summary of Product Characteristics (SmPC), and Rest of World (ROW) labels for lifecycle products.
• Support labeling governance activities by collaborating with the team lead and GLL/RLL to prepare materials, attend the governance meeting, and record accurate minutes for upload into the electronic document management system.
• Ensure labeling content complies with applicable regulatory requirements (e.g., FDA, EMA, ICH) and internal standards.
• Collaborate with cross‑functional teams (Safety, Medical, Legal, Regulatory Strategy) to gather input and align on labeling changes.
• Support responses to health authority q...