Regulatory Affairs Manager - 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.