Regulatory Affairs Senior Associate

Group Purpose

Facilitate patient access to Amgen products in Japan through executing the development and regulatory plans; providing strategic regulatory expertise; interfacing with agencies on regulators; 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 involvingJapan 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