Global Labeling Strategy Architect

Alnylam Pharmaceuticals; Cambridge (MA); Hybrid; USD 120,000 - 170,000; Full time

Job summary

Alnylam Pharmaceuticals is seeking an experienced labeling professional to join our labeling strategy team. The role leads cross-functional teams to develop initial product label content and strategy through the Target Label Process (TLP) and ensures CCDS alignment.

The ideal candidate will draft labeling content, provide strategic guidance on labeling regulations, and coordinate with regulatory, compliance, and operations to deliver submission-ready labeling components across US, EU, and global

Qualifications

• Experience in regulatory affairs with labeling content development.
• 2+ years in a labeling role drafting prescribing information.
• Knowledge of US/EU/global labeling regulations.
• Detail-oriented with ability to manage multiple projects.

Responsibilities

• Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional teams.
• Create, revise, and maintain CCDS for Alnylam's products in collaboration with CLTs.
• Develop labeling strategies and Target Label Profiles.
• Provide strategic guidance regarding labeling regulations, trends, and competitor labeling.
• Review impact of health authority labeling legislation or guidelines on products.
• Lead regional labeling development aligning with CCDS and health authority requirements.
• Prepare responses to labeling-related queries from health authorities.
• Coordinate labeling activities with internal and external partners as required.
• Assist with submissions to health authorities and ensure regulatory compliance.
• Track data sources supporting labeling claims and history of negotiations.
• Support growth of Global Labeling function and design appropriate systems.

Skills

Drafting labeling content

Cross-functional leadership

Written communication

Attention to detail

Job description

Alnylam Pharmaceuticals is seeking an experienced labeling professional to join our labeling strategy team. The role leads cross-functional teams to develop initial product label content and strategy through the Target Label Process (TLP) and ensures CCDS alignment.

The ideal candidate will draft labeling content, provide strategic guidance on labeling regulations, and coordinate with regulatory, compliance, and operations to deliver submission-ready labeling components across US, EU, and global