Manager, Regulatory Affairs – Global Labeling, PDx

Job Description Summary

The Manager, Regulatory Affairs – Global Labeling is responsible for developing and executing global labeling strategies for assigned PDx products, with primary accountability for US FDA labeling activities and US Prescribing Information. The role partners with Clinical, CMC, Safety, Medical, Commercial, global Regulatory Affairs and regional Regulatory Affairs teams to ensure labeling is scientifically sound, globally aligned, and supports product development, registration, lifecycle management, and commercialization.

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.