Director, Regulatory Affairs (Labeling)

Role: Director of Regulatory Affairs, leading global regulatory labeling strategy for Arrowhead Pharmaceuticals' RNAi therapeutics. Responsibilities: develop and oversee cross-functional label development, review and approve labeling documents (Target Product Labeling, CCDS, regional labels), ensure compliance with evolving regulations, negotiate with authorities, and support labeling updates and communication. Collaborate with clinical, medical, market access, and commercial teams; monitor regulatory environment; and participate in process improvements. Requirements: Bachelor's in life sciences or related field; 8+ years in biopharma regulatory labeling, with experience across multiple geographies; strong knowledge of labeling regulations, FDA guidance, and document management; experience leading cross-functional teams and negotiations. Preferred: familiarity with regulatory information systems (e.g., Veeva RIM), emerging AI technologies, and global inspection readiness. High-Value: role involves global regulatory labeling strategy for innovative RNAi drugs, with responsibilities spanning development, review, and compliance, supporting products in development and post-approval phases. Work setup: not specified, likely on-site or hybrid based on standard industry practices.