Associate Director, Regulatory Affairs

Role: Associate Director of Regulatory Affairs Strategy, leading regulatory planning and submissions for Alnylam's pipeline programs, with a focus on US regulatory interactions. Responsibilities: serve as US Regional Lead or Regulatory Program Lead for early pipeline assets, develop and execute regulatory strategies, prepare and submit key dossiers (INDs, CTAs, NDAs, expedited pathways), coordinate responses to authorities, represent RA on cross-functional teams, and provide regulatory intelligence. Requirements: Bachelor's degree, 6+ years of Regulatory Affairs experience in biotech/pharma, with at least 8 years industry experience; strong knowledge of global regulations, regulatory filings, and electronic submission processes; excellent communication and project management skills; ability to work collaboratively across departments and with external agencies. High-Value: focus on biologics or nucleic acid therapeutics, early development stage, US regulatory leadership, involvement in global submissions, and cross-functional team engagement. WorkSetup: hybrid model with 2 onsite days in Cambridge, MA or Philadelphia, PA.