Develop and execute regulatory affairs (RA) activities from the development to the life cycle management, with collaborative with global and Japan stakeholders.
Key Responsibilities:
Lead regulatory affairs interactions with Health Authorities (HAs)
Oversee New Drug Application (NDA) and supplemental NDA (sNDA) submissions
Manage Japan NDA preparation and support Health Authority review for approval
Prepare regulatory components of the Japan CTD, including the Approval Application Form and Module 1
Lead the development and maintenance of electronic Japanese Package Inserts (J-PI)
Serve as the Regulatory Affairs representative for SOP/Work Instruction updates and process improvement initiatives
| 職務経験 | 3年以上 |
| キャリアレベル | 中途経験者レベル |
| 英語レベル | ビジネス会話レベル |
| 日本語レベル | ネイティブ |
| 最終学歴 | 大学卒： 学士号 |
| 現在のビザ | 日本での就労許可が必要です |
Experience in Research & Development, particularly in Regulatory Affairs
Proven track record of collaboration with cross-functional teams and global stakeholders
Native-level Japanese and Advanced English
Strong stakeholder management skills
正社員
給与800万円 ~ 1500万円
業種医薬品
大手企業 (300名を超える従業員数) - 外資系企業
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