Senior Manager, Global Regulatory Labeling Strategy - Remote

Role Summary

Senior Manager, Global Regulatory Labeling Strategy - Remote. Responsible for the development and implementation of labeling content and strategy for assigned product(s) across stages of drug development, including updates to TLP, CCDS, USPI, and EU SmPC, with support for high complexity products.

Responsibilities

• Leads labeling cross-functional teams, facilitates discussions on labeling strategies and content, and ensures cross-functional collaboration and alignment with appropriate supervision.
• Assists in developing labeling strategies and content and ensuring cross-functional alignment for other medium/high complexity products.
• Coordinates the process to obtain labeling approval from the Global Labeling Oversight Committee (GLOC) and facilitates discussions to ensure cross-functional collaboration and alignment of labeling strategy and content at all levels.
• Ensures preparation and alignment of GLOC Chair(s) and members through respective functions.
• Authors revised TLP, CCDS, USPI and/or EU SmPC for assigned products, obtaining input and approval from all relevant functions with appropriate 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.
• Interfacing 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 alignment of local labeling with CCDS for assigned products, including assessment of exceptions and deferrals; provides support to Local Affiliates for responses to health authority requests and labeling exceptions.
• Escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies; strengthens relationships among labeling teams and cross-functional functions.
• Conducts precedent searches and analyzes labeling trends to develop strategies and labeling language for assigned product labels to ensure consistency with product strategy and claims.
• Represents Global Labeling at the Global Regulatory Team (GRT) and coordinates with US/EU Labeling Operations, Labeling Devices Lead, and Labeling Compliance; supports Health Authority Inspections with labeling information requests.
• Assists in managing labeling deliverables for medium/high complexity products, including review/editing of labeling documents and coordinating local updates/exception processes.
• Oversees external vendor labeling activities for assigned products to ensure coordination and quality.

Qualifications

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

Skills

• Cross-functional leadership and collaboration
• Regulatory labeling strategy and content development
• Project management and coordination
• Communication with Health Authorities
• Analytical thinking and precedent research

Education

• Bachelor‚Äôs degree required; advanced scientific degree preferred