Director, Regulatory Affairs (Labeling)

Role: Director of Regulatory Affairs leading global regulatory labeling strategy for Arrowhead’s RNAi-based therapeutics, overseeing labeling development across all phases and post-approval. Responsibilities: develop and manage target, core, and regional labeling documents; collaborate with R&D, medical, market access, and commercial teams; negotiate with health authorities; ensure labeling compliance with evolving regulations; oversee labeling quality control; support labeling updates and regulatory submissions; monitor global regulatory environment and facilitate policy updates; contribute to continuous improvement initiatives. Requirements: Bachelor's in life sciences or related field; 8+ years in biotech/pharma, with experience managing product labeling across multiple geographies; knowledge of drug development, FDA/EMA labeling guidelines, and cross-functional leadership; proficiency in regulatory documentation and document formatting. Preferred: experience with regulatory information management systems (e.g., Veeva RIM), emerging AI applications in regulatory operations, and global inspection readiness. High-Value: experience in biopharma labeling, global regulatory environment, biologics or RNAi therapeutics, and cross-functional stakeholder engagement. Work setup: location-specific; salary range approximately $210,000-$240,000 USD.