R&D Regulatory Affairs Sr. Scientist（開発薬事）

Benefits

Parental leave

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Non-birth-parent leave

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Family-building benefits

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Mental health support

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Relocation assistance

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Childcare support

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Learning budget

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Verification

Source-linked last checked Jun 7, 2026

Salary

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401(k) match

Listed Source: EMPLR_CONTRIB_INCOME_AMT. source Last checked Jun 7, 2026.

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Schedule

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Weekend work

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Application

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Assessment

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Deadline

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Where they hire

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About this role

R&D Regulatory Affairs Sr. Scientist（開発薬事） JPN - Tokyo - Chiyoda Job Description 業務内容： 1. グローバル戦略に沿った、効率的かつ付加価値の高い新薬等の国内開発薬事戦略の構築 2. 規制当局（厚生労働省、独立行政法人医薬品医療機器 総合機構など）との窓口業務 3. 承認申請・審査資料、機構相談資料、照会事項に対する回答等へのレビュー・アドバイスを通じ、当局提出文書の質の向上に資する 4. 承認申請・審査資料、機構相談資料、照会事項に対する回答等の作成・提出のコーディネーション 5. 新薬承認申請に関する薬事情報の収集・分析、関係者への提供／共有 6. 当局対応（30日調査、対面助言、申請準備、審査対応）の際の、米国本社も含めた社内調整（スケジュール管理） 必須条件： ＜経歴・経験＞ 製薬系会社又は医薬品開発に関する勤務経験 承認申請・審査対応の経験

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