Global Labeling Strategy Director — Lead US Labeling

Alnylam Pharmaceuticals; Cambridge (MA); On-site; USD 200,000 - 300,000; Full time

Job summary

Alnylam Pharmaceuticals seeks a Director of Regulatory Affairs, Global Labeling Strategy (US) to lead the US labeling function within the Global Labeling team. The role shapes CCDS, CPI, and TLPs, guiding evidence plans and negotiation pathways for multiple regions.

You will influence study design, evidence elements, and health authority interactions across disciplines. Ideally, you bring 12+ years in biopharma regulatory affairs with strong labeling experience, strategic judgment, and

Qualifications

• BS/BA degree (science or related discipline preferred)
• Minimum of 12 years in biopharma Regulatory Affairs, Pharmacovigilance, or Medical Writing/Communications
• Minimum of 7–8 years in Regulatory Affairs with at least 5 years in labeling strategy
• Thorough knowledge of US, EU and Global labeling regulations and guidance
• Ability to connect target claims to study design, endpoints, and evidence
• Experience with leading cross-functional teams and influencing senior stakeholders
• Familiarity with AI-enabled research tools, source verification, and regulatory judgment
• Strong drafting, negotiation, and communication skills
• Ability to stay current on regulatory developments affecting labeling

Responsibilities

• Lead US Labeling within Global Labeling, building scalable capabilities
• Interpret data and craft labeling strategies across regions
• Develop and maintain CCDS, CPI, and Target Label Profiles
• Partner with Clinical Development, Biostatistics, Medical, Safety, Regulatory, and Market Access
• Influence study design, endpoints, and evidence required for labeling
• Synthesize regulatory intelligence, literature, and competitor analysis
• Lead scenario-based claim strategies and negotiation plans
• Represent Global Labeling in governance forums and cross-functional teams
• Oversee preparation of labeling materials and health authority responses
• Mentor and grow the Regulatory Labeling Strategy team
• Coordinate labeling activities with internal and external partners
• Support systems and process design for global labeling

Skills

Regulatory strategy

Labeling strategy

GxP knowledge

Cross-functional leadership

AI-enabled research

Project management

Negotiation

Technical writing

Strategic thinking

Education

Bachelor’s degree in life sciences

Graduate degree desirable

Tools

CCDS

Target Label Profiles

Job description

Alnylam Pharmaceuticals seeks a Director of Regulatory Affairs, Global Labeling Strategy (US) to lead the US labeling function within the Global Labeling team. The role shapes CCDS, CPI, and TLPs, guiding evidence plans and negotiation pathways for multiple regions.

You will influence study design, evidence elements, and health authority interactions across disciplines. Ideally, you bring 12+ years in biopharma regulatory affairs with strong labeling experience, strategic judgment, and