Associate Director, Regulatory Affairs

Role: Associate Director of Regulatory Affairs Strategy, leading regulatory submissions and strategies for early-stage programs within Alnylam's pipeline, with a focus on US regulatory interactions. Responsibilities: serve as US Regional Lead or Program Lead, develop regulatory strategies, compile and submit INDs, CTAs, NDAs, and expedite applications; coordinate responses to authorities; lead global regulatory teams; provide strategic advice and regulatory intelligence; manage regulatory documentation and compliance. Requirements: Bachelor's degree, 6+ years in Regulatory Affairs within biotech/pharma, 8+ years industry experience, strong knowledge of US and international regulations, excellent communication, project management, and cross-functional collaboration skills. Preferred: experience with electronic submissions, regulatory filings, and working on RNAi or biologics programs. HighValue: focus on early pipeline programs, US regulatory leadership, IND/CTA/NDA submissions, cross-functional team engagement, hybrid role based in Cambridge, MA or Philadelphia, PA.