Director, Regulatory Affairs, Global Labeling Strategy (US)

Role: Lead US Global Labeling for Alnylam, overseeing strategy development, process building, and team management within Regulatory Affairs. Primary objectives include implementing differentiated global labeling strategies, aligning regional labels with global standards, and supporting product development and commercialization. Responsibilities encompass shaping evidence-based labeling claims, translating strategic ambitions into actionable evidence plans, influencing study design, and negotiating with health authorities. The role also involves overseeing labeling submissions, ensuring compliance with regulatory requirements, and mentoring the labeling team. Qualifications: BS/BA in science or related field; minimum 12 years in biopharma, with 7-8 years in Regulatory Affairs and at least 5 years in labeling strategy. Strong knowledge of US, EU, and global labeling regulations is essential. Skills include strategic judgment, regulatory intelligence synthesis, AI-enabled research familiarity, cross-functional influence, and excellent communication. Experience managing core labeling documents (CCDS, TLPs), developing Target Label Profiles, and leading teams is preferred. High-Value: Focus on RNAi therapeutics, multiple disease areas, regulatory stages spanning development to post-marketing, and global regulatory compliance. Leadership role within cross-functional teams, with a focus on strategic labeling initiatives and process innovation.