Manager, Regulatory Affairs – Global Labeling, PDx

Role: Manager, Regulatory Affairs – Global Labeling, focusing on developing and executing US and global product labeling strategies for biopharma products. Responsibilities: lead US FDA labeling activities, support lifecycle management, align US labeling with global strategies, prepare USPI and FDA labeling updates, support FDA interactions, and manage CCDS creation and maintenance; collaborate cross-functionally with Clinical, CMC, Safety, Medical, Market Access, Legal, and Regulatory teams; ensure compliance and inspection readiness; track global labeling changes and maintain documentation. Requirements: 7+ years in Regulatory Affairs with significant labeling experience; deep knowledge of FDA labeling requirements and US regulatory submissions; experience with CCDS development. Preferred: FDA interaction experience, knowledge of EU/global labeling standards, familiarity with Veeva RIM or similar systems; degree in Life Sciences or Pharmacy. High-Value: US FDA labeling, global alignment, CCDS management, cross-functional collaboration. WorkSetup: not specified; likely hybrid or office-based given industry norms.