Regulatory Affairs Manager

Company Overview
バイオ系外資製薬メーカー/ランキング10位以内/パイプライン充実

Job Description
This role conducts regulatory activities for domestic products, and supports drug development or commercialization activities in Japan based on the regulatory and submission strategy by serving as Japanese regulatory staff. This role develops and maintains good relationship with Japanese Health Authorities to facilitate drug approvals. This role also provides regulatory guidance and supports various Amgen teams by involving Japan Project Team and Global Product Strategic Team.

Key Activities:
- Represent Development Regulatory Affairs on various cross-functional teams, including Project teams, Bland strategy teams, etc.
- Develop and implement Japan regulatory strategy for the entire 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) and Orphan Drug Applications, etc.
- Work cross-functionally with the various 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 products.
- 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

Requirements
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 of oncology/hematology drug in Japan.
- Ability to 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 manages multiple assignments and processes
- Communication skills in English (TOEIC score ≥780, desirable)
- Native level Japanese
- Computers: Microsoft Outlook/Word/ Excel/PowerPoint

Education & Experience:
- Bachelors in scientific discipline; more than 10 years pharmaceutical industry with more than 5 years in regulatory for oncology/hematology drugs.
- Advanced degree preferred.

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