The Senior Manager/Associate Director, Regulatory Affairs integrates and applies knowledge of US and ex-US regulatory guidelines to AVROBIO’s pipeline development programs. Ensures global strategies are successfully implemented and executed across AVROBIO’s portfolios. Interfaces cross-functionally both within AVROBIO and external service providers/partners. Participates as a member of the project program development team(s) to build awareness of Regulatory Authority requirements and timing for submissions. Demonstrates leadership and has comprehensive understanding of global regulations and guidelines to address and overcome challenges that arise during development and commercialization. Collaborates with functional groups to plan, author, compile and submit high-quality original applications, amendments, supplements and responses to inquiries from FDA and international Health Authorities. Successfully communicates and negotiates directly and indirectly with international Health Authorities as necessary.