Director, Global Regulatory Affairs

Role: Director, Global Regulatory Strategy responsible for developing and implementing global regulatory plans for Stoke's RNA-based therapeutics, including the Phase 3 program for zorevunersen in CNS indications. Responsibilities include defining regulatory strategies, leading agency interactions, preparing submissions, and ensuring compliance across development stages. Acts as primary contact with agencies like FDA, manages risk assessments, and supports process improvements. Requirements: minimum 8 years in Regulatory Affairs within pharma or biotech, with experience in rare diseases and neurology preferred; advanced degree (MS, Ph.D., or equivalent) in a scientific discipline; proven track record in major regulatory submissions and agency negotiations. HighValue: RNA therapeutics, antisense oligonucleotides, CNS indications, Phase 3 development, global regulatory strategy, agency interactions, rare disease focus. WorkSetup: hybrid role based in Bedford/Waltham, MA; travel approximately 10%.