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| 部署・役職名 | Global Regulatory Affairs Manager |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
－ Develop and manage effective working relationships with the PMDA, MHLW, and other local health authorities, Regional and other key stakeholders including QA, and Clinical Development, Project Management － Support in the preparation of regulatory dossiers for submission to PMDA, MHLW, and other local health authorities in order to obtain registration of the product － Provide tactical and strategic regulatory leadership to the team and manage all regulatory programs, including new product introduction, continuous improvement activities and/ or compliance related projects. － Lead the regulatory and support vendors on planning and follow－up at consultation meetings, CTN, and NDA. － Efficient communication with the applicants, strategies preparation and presentation for institutions （e.g. PMDA, MHLW, and other local health authorities）. － Maintain company Licences including new applications and renewals. － Maintain the transparently between Regional （APAC） Regulatory/QA and PMDA, MHLW, and other local health authorities communications. －Regulatory files preparation and updating, including administrative and technical documents for new and modified products and/ or for eventual submissions to PMDA, MHLW, and other local health authorities － Participate in the development or implementation of clinical trial protocols. |
| 応募資格 |
【必須（MUST）】 － Bachelor's degree－ Experience in leading Regulatory Affairs for a pharmaceutical company － Business－level proficiency in Japanese; English proficiency is needed to collaborate with headquarters overseas － Experience in Regulatory Affairs dealing with PMDA, MHLW, and other local health authorities. － Strong experience with CTD/eCTD submissions in clinical and commercial regulatory filings. |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2025/09/17 |
| 求人番号 | 5734635 |
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