Global Labeling Strategy Lead

Parexel; Providence (RI); On-site; USD 180,000 - 240,000; Full time

Job summary

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy for a diverse portfolio of therapies. You will own TPL development for early‑stage assets, CCDS, and regional labeling strategies, coordinating with Regulatory, Clinical, Safety, Medical, and Commercial teams.

This role requires strategic leadership, strong medical writing, and the ability to guide cross‑functional teams through regulatory submissions and lifecycle labeling across global markets.

Qualifications

• Experience leading cross-functional labeling initiatives and governance.

Responsibilities

• Provide strategic leadership for global labeling activities across CCDS, US, EU, ROW, and major markets.
• Lead TPL development for early‑phase assets and ensure CCDS alignment across regions.
• Coordinate Health Authority responses and labeling updates in regulatory submissions and lifecycle management.
• Interface with project teams to ensure consistency and local compliance with CCDS.
• Communicate labeling strategy, risks, and plans to senior management and cross-functional partners.

Skills

Leadership

Communication

Regulatory strategy

Global labeling

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences

Advanced degree (MSc/PhD/PharmD) preferred

Tools

Veeva RIMS

Veeva eDMS

Apollo

Docubridge

Trackwise

Microsoft Office

SharePoint

Adobe Acrobat

Job description

Parexel is seeking a Senior/Global Regulatory Labeling Strategist to lead global labeling strategy for a diverse portfolio of therapies. You will own TPL development for early‑stage assets, CCDS, and regional labeling strategies, coordinating with Regulatory, Clinical, Safety, Medical, and Commercial teams.

This role requires strategic leadership, strong medical writing, and the ability to guide cross‑functional teams through regulatory submissions and lifecycle labeling across global markets.