Manager, Regulatory Affairs – Global Labeling, PDx

Key Responsibilities 

Global Labeling Strategy 

• Lead global labeling strategy for assigned products, with primary focus on US FDA requirements and labeling expectations. 

• Provide labeling input to development programs, lifecycle management activities, and regulatory submissions. 

• Ensure alignment between US labeling, CCDS, and regional implementation strategies. 

FDA Labeling Leadership 

• Lead preparation and review of US labeling content, including USPI and FDA labeling updates. 

• Support FDA interactions and labeling negotiations. 

• Assess regulatory risks and communicate the impact of FDA feedback on development and commercialization plans. 

Cross-Functional Collaboration 

• Partner with Clinical, CMC, Safety, Medical, Market Access, Commercial, Legal, and Ad Promo teams to develop clear and defensible labeling positions. 

• Translate complex regulatory requirements into business-relevant recommendations. 

Governance & Compliance 

• Support labeling governance processes and ensure inspection-ready documentation. 

• Drive timely implementation of labeling changes and continuous process improvement. 

• Contribute to labeling metrics, systems, and best practices across the organization. 

CCDS Alignment & Global Implementation  

• Support CCDS creation, maintenance, version control, and change-control activities, ensuring US labeling decisions are assessed for global impact and properly reflected in global labeling governance. 

• Coordinate with global regulatory leads and regional RA teams to evaluate local implementation requirements, document deviations or exceptions from CCDS, and maintain transparent rationale for regional differences. 

• Track implementation of labeling changes across US and global markets, including milestones, dependencies, approvals, exceptions, and closure status. 

• Maintain labeling trackers, action logs, decision records, and implementation status to support global visibility and inspection readiness. 

Required Qualifications 

• 7+ years of Regulatory Affairs experience, including significant experience in labeling. 

• Strong knowledge of FDA labeling requirements and experience supporting US regulatory submissions. 

• Experience developing and maintaining US labeling and/or CCDS. 

• Ability to influence cross-functional teams and manage complex projects. 

• Excellent written and verbal communication skills. 

Preferred Qualifications

• Experience interacting with FDA on labeling matters. 

• Knowledge of EU and global labeling requirements. 

• Experience with Veeva RIM or similar regulatory systems. 

• Degree in Life Sciences, Pharmacy, or related field.