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 the regulatory strategy and facilitate submission of data packages to the EMA. The role is expected to serve as an EU Regional Lead for our mid/late-stage CNS programs and may have the opportunity to be the Regulatory Program Lead for early programs in Alnylam pipeline. 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 will represent RA on multidisciplinary product development subteams and Global Regulatory Team. Additional responsibilities include involvement in the writing and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on EU regulatory requirements, and interp...