Position Title: Senior Manager, Global Labeling Strategy
Overview:
The Senior Manager, Global Labeling Strategy is responsible for ensuring timely and accurate updates to key labeling documents, including the Company Core Data Sheet (CCDS), United States Package Insert (USPI), and European Summary of Product Characteristics (SmPC) for products approved via the Centralized, Mutual Recognition, or Decentralized Procedures.
Key Responsibilities:
* Lead labeling strategy in collaboration with the Global Regulatory Team Leader, aligning with overall regulatory objectives and providing subject matter expertise on global labeling regulations, processes, and competitive intelligence.
* Act as the primary point of contact for the Labeling Strategy Team (LST).
* Partner cross-functionally with stakeholders in Regulatory Strategy, Safety, Clinical Development, and Medical Affairs to support labeling content development and review.
* Serve as the key interface with Country Regulatory Managers to ensure global alignment and timely submission of labeling updates.
* Oversee cross-functional labeling review and approval processes to drive high-quality, compliant, and efficient outputs.
* Coordinate planning and execution of all labeling-related activities across global teams.
* Support responses to Health Authority inquiries and inspection-related labeling requests.
* Review country-specific labels to ensure alignment with global labeling and regulatory standards.
Qualifications:
* Solid understanding of global labeling regulations, requirements, and processes.
* Demonstrated expertise in at least one major market (e.g., US, EU) and experience with CCDS management.
* Familiarity with GxP principles and regulatory procedures across the product lifecycle.
* Strong knowledge of drug development and commercialization pathways.
* Proven ability to assess and manage labeling strategies in alignment with regulatory and business objectives.
* Excellent collaboration skills with the ability to build relationships across cross-functional and global teams.
* Strong leadership, facilitation, and decision-making skills, especially within multidisciplinary environments.
* Project management experience, particularly with moderately complex initiatives.
* Exceptional written and verbal communication skills.
* High attention to detail and ability to synthesize complex scientific and clinical information.
* Creative problem-solver with a proactive and solutions-oriented mindset.