Group Purpose

　　Facilitate patient access to Amgen products in Japan through executing the development and regulatory plan s ; providing strategic regulatory expertise; interfacing with agencies on regulat ors ; aligning with key cross-functional partners; integrating into Amgen’s commercialization process, and continuously improving our processes and developing our talent

　　Job Summary

　　This role supports regulatory and commercialization activities for Amgen products in Japan leading by RA Manager or Senior Manager. This role also supports development and maintenance of good relationship with Japanese Health Authorities to facilitate drug approvals. This role may provide regulatory guidance and support various Amgen teams by involving Japan Project Team and Global Product Team.

　　Live

　　What you will do

　　Responsibilities:

　　Support RA Manager or Senior Manager to coordinate and conduct PMDA consultations from planning to finalization of the official minutes

　　Support kick-off meetings for local regulatory deliverables including Clinical Trial Notification (CTN), New Drug Application (NDA) submissions, and agency interactions by RA Manager or Senior Manager

　　Work cross-functionally with the various Amgen teams to support activities related to CTNs and NDAs

　　Assemble and provide local regulatory input to a variety of local and global teams in a timely manner

　　Execute and maintain compliance for all documents to be submitted to Health Authorities

　　Win

　　What we expect of you

　　Qualifications

　　Bachelor’s degree and 6 years of directly related experience including 3+ years of experience in Regulatory Affairs

　　Over 10 years experiences in Research & Development of pharmaceutical industry including at least 5 years experiences in regulatory affairs with experiences for supporting PMDA consultations and CTN submission of pharmaceuticals in Japan

　　Team work] working in matrix environments including global teams as the One Team

　　Communication skills in both Japanese and English

　　Ability to understand scientific/clinical information

　　Support a few projects in parallel

　　Computers: Microsoft Outlook/ Word/ Excel/Power Point