Associate Director, Global Labeling
Core
Develop initial product label content and strategy through the Target Label Process (TLP) for Alnylam's RNAi therapeutics.
Role type
Associate Director, Global Labeling
Builds
Company Core Data Sheets (CCDS), regional labeling, and submission-ready labeling components for health authorities.
Domain
Biopharmaceuticals / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
drafting prescribing information, developing labeling strategies, cross-functional team leadership, regulatory impact analysis, health authority query response, process design
Preferred skills
graduate degree, experience in Pharmacovigilance or Medical Writing
Technologies
none stated
Responsibilities
Represent Global Labeling on product-specific Global Regulatory Teams; create and maintain Company Core Data Sheets (CCDS); develop labeling strategies and Target Label Profiles; provide strategic guidance on labeling regulations and trends; review and communicate impact of health authority legislation changes; lead development of regional labeling; prepare responses to labeling-related queries from health authorities; coordinate labeling activities with internal and external partners; partner with Regulatory Technology and Operations to ensure submission compliance; track data sources supporting labeling claims; support growth of the Global Labeling function by designing systems and processes.
Seniority
Senior, hands-on IC with strategic guidance responsibilities