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| 部署・役職名 | Regulatory Affairs Manager （2 Positions） |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Position 1: Regulatory Affairs Manager （New Drug Development） Location: Tokyo, Japan Role Overview: Leading regulatory strategy and submissions for new drug development programs in Japan market. Key Responsibilities: • Drive regulatory strategy for new drug development programs • Lead regulatory submissions and authority consultations • Develop CTD clinical parts and consultation materials • Manage health authority interactions • Support in/out licensing activities from regulatory perspective • Collaborate with global development teams Required Qualifications: • 5＋ years experience in new drug development regulatory affairs • Strong knowledge of Japanese pharmaceutical regulations • Scientific background （Medical/Pharmaceutical/Life Sciences degree） • Bilingual in Japanese and English • Experience in global development programs Position 2: Regulatory Affairs Manager （Generic Products） Location: Tokyo, Japan Role Overview: Leading regulatory strategy and submissions for generic drug products, including complex generics and authorized generics. Key Responsibilities: • Lead regulatory strategy for generic product development • Manage bi－annual submission cycles for generic products • Prepare regulatory submissions and authority consultations • Review CMC documentation • Support business development activities • Coordinate with cross－functional teams Required Qualifications: • 5＋ years experience in generic drug regulatory affairs • Strong knowledge of Japanese pharmaceutical regulations • Scientific background （Medical/Pharmaceutical/Life Sciences degree） • Bilingual in Japanese and English • Experience with CMC documentation preferred Common Features for Both Positions: • Language: 40％ English / 60％ Japanese • Location: Tokyo HQ • Reports to: Director, Regulatory Strategy • Employment Status: Full－time permanent |
| 労働条件 |
Common Features for Both Positions: • Language: 40％ English / 60％ Japanese • Location: Tokyo HQ （can work hybrid and remotely with business trips to Tokyo HQ） • Reports to: Director, Regulatory Strategy • Employment Status: Full－time permanent |
| 応募資格 |
【必須（MUST）】 Position 1: Regulatory Affairs Manager （New Drug Development）Required Qualifications: • 5＋ years experience in new drug development regulatory affairs • Strong knowledge of Japanese pharmaceutical regulations • Scientific background （Medical/Pharmaceutical/Life Sciences degree） • Bilingual in Japanese and English • Experience in global development programs Position 2: Regulatory Affairs Manager （Generic Products） Required Qualifications: • 5＋ years experience in generic drug regulatory affairs • Strong knowledge of Japanese pharmaceutical regulations • Scientific background （Medical/Pharmaceutical/Life Sciences degree） • Bilingual in Japanese and English • Experience with CMC documentation preferred |
| 受動喫煙対策 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
| 更新日 | 2025/07/17 |
| 求人番号 | 5180724 |
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転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です