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 drug development stages, 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 for assigned product(s), and ensures cross-functional collaboration and alignment with appropriate supervision.
• Assists in developing labeling strategies and content and ensures cross-functional alignment for medium/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.
• 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 with input from relevant areas; develops and executes labeling implementation plans to incorporate new data and health authority feedback into CCDS/USPI/EU SmPC.
• Authors/manages outgoing communications regarding significant labeling changes and CCDS changes with supervision.
• Uses project management to interface with global labeling sub-functions to ensure timely 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; assesses exceptions and deferrals; supports Local Affiliates for health authority responses and local labeling deferrals.
• Escalates issues to Global Labeling management and the Global Regulatory Lead; proposes risk mitigation strategies and strengthens relationships across functions (clinical, safety, medical affairs, commercial).
• Conducts precedent searches and analyzes labeling trends; develops strategies and labeling language to ensure consistency with product strategy and claims.
• Represents Global Labeling at the Global Regulatory Team; liaises with labeling operations and compliance to meet objectives and timelines; supports Health Authority inspections with labeling information requests.
• Assists in managing labeling deliverables for medium/high complexity products; coordinates local updates/exception processes and leads labeling working groups as needed.
• Oversees labeling activities managed by external vendors for assigned products, ensuring coordination and quality.

Qualifications

• BSc degree required or BA; advanced scientific degree (MSc/PhD/PharmD) preferred.
• 6+ years of pharmaceutical industry experience, including at least 4 years in labeling or regulatory-related roles.
• Knowledge of US and EU product labeling regulatory requirements and guidelines; familiarity with regional regulatory 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) for regulatory submissions with supervision.
• Ability to identify factors for regulatory recommendations and develop regulatory strategies based on requirements and competitive landscape.

Skills

• Cross-functional collaboration and stakeholder management
• Regulatory labeling strategy and content development
• Project management and document authoring
• Health Authority negotiations and communications
• Attention to regulatory compliance and timelines

Education

• Relevant degree in life sciences or related field; advanced degree preferred.

Additional Requirements

• Remote/work-from-home flexibility; Massachusetts - Virtual location referenced.