Global Labeling Strategy Director | Regulatory Innovator

Regulatory Jobs; Cambridge (MA); On-site; USD 250,000 - 360,000; Full time

Job summary

Alnylam seeks a Director of Regulatory Affairs, Global Labeling Strategy (US) to lead the US labeling function and shape global labeling processes. You will supervise labeling strategists and guide CCDS, CPI, and TLP development for investigational therapies and products.

The role requires strong regulatory expertise across US, EU, and global labeling regulations, with a focus on strategic evidence planning, AI-enabled research, and cross-functional collaboration to support compelling labeling

Qualifications

• Strong background in regulatory affairs and labeling strategies.
• Experience connecting target claims to study design and evidence packages.
• Ability to synthesize regulatory intelligence, literature, and data.

Responsibilities

• Lead US Labeling function within Global Labeling to build scalable processes.
• Strategically guide CCDS, CPI, and Target Label Profiles development.
• Collaborate across Clinical Development, Biostatistics, Medical, Safety, Regulatory and Market Access.

Skills

Regulatory strategy

Global labeling

Cross-functional leadership

AI-enabled research

Strategic communication

Education

B.S./B.A. in science

Graduate degree desirable

Job description

Alnylam seeks a Director of Regulatory Affairs, Global Labeling Strategy (US) to lead the US labeling function and shape global labeling processes. You will supervise labeling strategists and guide CCDS, CPI, and TLP development for investigational therapies and products.

The role requires strong regulatory expertise across US, EU, and global labeling regulations, with a focus on strategic evidence planning, AI-enabled research, and cross-functional collaboration to support compelling labeling