Global Labeling Strategy Director — Regulatory Innovation

Alnylam Pharmaceuticals; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Alnylam Pharmaceuticals seeks a Director of Regulatory Affairs, Global Labeling Strategy (US) to lead US labeling and coordinate with Global Labeling. You will shape CCDS, CPI, and Target Label Profiles to support the product portfolio.

This senior role partners with Clinical Development, Safety, Regulatory, and Market Access to design evidence plans, oversee labeling materials, and mentor a growing labeling team.

Qualifications

• Minimum of 12 years of professional experience in biopharmaceutical regulatory affairs, pharmacovigilance, and/or medical writing/communications.
• Minimum of 7–8 years in regulatory affairs, including at least 5 years in labeling strategy.
• Thorough knowledge of US, EU and global labeling regulations, standards and guidance.

Responsibilities

• Lead US Labeling function within the Global Labeling team and build scalable labeling capabilities.
• Translate labeling ambitions into actionable evidence plans in partnership with Clinical Development, Biostatistics, Medical, Safety, Regulatory, and Market Access.
• Develop and oversee Target Label Profiles, CCDS, and SOPs; manage core labeling activities.

Skills

Regulatory strategy

Cross-functional collaboration

Strategic judgment

AI-enabled research

Written and verbal communication

Leadership and mentoring

Education

BS/BA in science or related field

Graduate degree desirable

Tools

AI-enabled research tools

Job description

Alnylam Pharmaceuticals seeks a Director of Regulatory Affairs, Global Labeling Strategy (US) to lead US labeling and coordinate with Global Labeling. You will shape CCDS, CPI, and Target Label Profiles to support the product portfolio.

This senior role partners with Clinical Development, Safety, Regulatory, and Market Access to design evidence plans, oversee labeling materials, and mentor a growing labeling team.