Associate Director, Regulatory Affairs

Role: Associate Director of Regulatory Affairs Strategy, leading regulatory planning and submissions for early pipeline programs at Alnylam, with a focus on US and international agencies. Responsibilities: serve as US Regional Lead, develop regulatory strategies, oversee submission preparation and timely submission of INDs, CTAs, NDAs, and expedited pathways; coordinate responses to authorities, and represent RA in cross-functional teams and product development subteams. Requirements: Bachelor's degree with 6+ years in Regulatory Affairs within biotech/pharma, 8+ years industry experience, strong knowledge of regulations, experience with electronic submissions, and excellent project management skills. Preferred: strategic thinking, regulatory intelligence, and effective communication skills. High-Value: biologics, RNAi therapeutics, early clinical stages (preclinical/IND), US and global regulatory processes, cross-functional collaboration, hybrid work model with onsite presence in Cambridge, MA or Philadelphia, PA, with some travel.