Job Information
Amgen Development Regulatory Affairs Manager in Tokyo, Japan
Group Purpose
Facilitate patient access to Amgen products in Japan through executing the development and regulatory plans; providing strategic regulatory expertise for drug development; 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
Conducts regulatory activities for Amgen products in Japan
Support drug development or commercialization activities in Japan based on the regulatory and submission strategy by serving as Japan Regulatory Lead (JRL)
Develop and maintains good relationship with Japanese Health Authorities to facilitate drug approvals.
Provide regulatory guidance and supports various Amgen teams by involving Japan Development Team and Global Regulatory Team.
Key Activities
Represent Japan at Global Regulatory Team as Japan Regulatory Lead (JPRL) and on various cross-functional teams, including Japan Project teams, Japan Development Team, etc.
Develop and implement Japan regulatory strategy for the projects in Japan, aligned with global regulatory strategy as much as possible.
Responsible of leading health authority interactions and the preparation of regulatory submissions, which may include New Drug Applications (NDAs), Briefing Documents for various type of PMDA consultations, Clinical trial notifications (CTNs), Package Insert and Orphan Drug Applications, etc.
Work cross-functionally with the various Amgen teams related to NDAs, PMDA consultations and CTNs, etc.
Serve as the primary interface to Global regulatory lead and JAPAC Reginal regulatory lead of each product.
Responsible as the primary interface for MHLW and PMDA for product approval and clinical development.
Assemble and provide local regulatory input to a variety of local and global teams in a timely manner
Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
Execute and maintain compliance for all documents to be submitted to Health Authorities
Knowledge and Skills
Over 10 years experiences in Research & Development of pharmaceutical industry including at least 5 years experiences in regulatory affairs with experiences conducting PMDA consultations and CTN submission in Japan.
Work in matrix environments including global teams under global environment.
Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
Anticipates and prevents potential problems. Independently develops solutions that are thorough, practical and consistent with functional objectives
Work under minimal direction (with middle degree of autonomy)
Ability to understand scientific/clinical information
Organizational, communication and time management skills needed to manage multiple assignments and processes
Build good relationships with project team members and RA members
Communication skills in English (TOEIC score ≥780, desirable)
Native level Japanese
Computers: Microsoft Outlook/ Word/ Excel/Power Point
Education & Experience
- Bachelors in scientific discipline; more than 10 years pharmaceutical industry with more than 5 years experiences in development regulatory affairs (especially for oncology/hematology drugs). Advanced degree preferred.