Senior Manager, Global Regulatory Labeling Strategy - Remote

Role Summary

Senior Manager, Global Regulatory Labeling Strategy is responsible for the development and implementation of labeling content and strategy for assigned product(s) in various stages of drug development, including medium complexity products and updates to TLP, CCDS, USPI, and EU SmPC, and for providing support to high complexity products.

• Leads labeling cross-functional teams, facilitates discussions on labeling strategies and content for assigned product(s), and ensures cross-functional collaboration and alignment with appropriate supervision and guidance.
• Assists in the development of labeling strategies and content and ensures cross-functional alignment for other medium and/or high complexity products.
• Coordinates the process to obtain labeling approval by the Global Labeling Oversight Committee (GLOC) and facilitates discussions to ensure cross-functional collaboration and alignment of labeling strategy and content at all levels, with supervision and alignment with TAU/MPD Labeling Lead.
• Ensures preparation and alignment of GLOC Chair(s) and GLOC members through respective functions.
• Authors revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from relevant functional areas with annotations and supporting documentation.
• Develops and executes labeling implementation plans to incorporate new data and Health Authority feedback into CCDS, USPI, and EU SmPC, ensuring up-to-date information and regulatory compliance while minimizing risk of write-offs.
• Authors/manages outgoing communications regarding significant labeling changes and CCDS changes for assigned products.
• Employs project management skills to interface with global labeling sub-functions to ensure timely end-to-end label creation and Health Authority submission; participates in label negotiations with Health Authorities.
• Ensures labeling content conforms to regulatory requirements.
• Manages the process for alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals; supports Local Affiliates in responses to health authorities and labeling exceptions/deferrals.
• Escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies; fosters robust cross-functional relationships to ensure effective communication of labeling strategy and content.
• Conducts precedent searches and analyzes labeling trends to develop strategies and labeling language for assigned product labels to ensure consistency with product strategy and competitive labeling.
• Represents Global Labeling at the Global Regulatory Team (GRT); liaises with US/EU Labeling Operations, Labeling Devices Lead, and Labeling Compliance to meet objectives and timelines; participates in cross-functional task-forces and initiatives; supports Health Authority inspections with labeling information requests for assigned products.
• Assists in managing labeling deliverables for medium and/or high complexity products, including reviewing and editing labeling documents, leading LWG meetings, and coordinating local update/exception processes.
• Oversees labeling activities managed by external vendors for assigned products to ensure coordination, timely delivery, and quality.

• Required:
  
  BSc degree (preferred; BA accepted); advanced scientific degree (MSc, PhD, or Pharm
  
  D) preferred.
• Required:
  
  6+ years of pharmaceutical industry experience, including at least 4 years in labeling or a combination of 4+ years regulatory and/or related experience.
• Required:
  
  Knowledge of US and EU product labeling regulatory requirements and guidelines; familiarity with US and/or EU regulatory requirements and guidelines; familiarity with other regional regulatory nuances.
• Required:
  
  Basic knowledge of scientific principles and regulatory/quality systems relevant to drug development.
• Required:
  
  Ability to co-author, revise, and update product labeling (CCDS, USPI, EU SmPC) for regulatory submissions with supervision and guidance.
• Required:
  
  Ability to identify factors and requirements for regulatory recommendations; ability to develop regulatory strategies based on regulatory requirements and competitive landscape.

• Bachelor's degree required (BSc/BA); advanced scientific degree (MSc, PhD, or Pharm
  
  D) preferred.