Associate Director, Regulatory Affairs

Overview The Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead and define the regulatory strategy, facilitate submission of data packages to the US FDA and other international health agencies (HA). The role is responsible for planning and coordinating all aspects of regulatory submissions necessary to support product development, clinical trials and product registration. The role is expected to serve as a USRegional Lead for for early programs in Alnylam pipeline. The role will guide regulatory strategy for the assigned programs and represent RA on multidisciplinary product development subteams and program Leadership Teams on those programs.…