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| 部署・役職名 | Regulatory Affairs, Associate Director |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
• Responsible for managing and developing regulatory strategies and project workflow • Responsible for creating and delivering documentation and implement effective submission • Lead the submission/approval strategy and execute the project in light of PMDA requirements, business needs, reimbursement strategy, system development, etc. together with the relevant teams • Assess product changes to capture any impact to existing or in－process product registrations and letters to file and develop strategies. • Collaborate and document regulatory activities for clinical studies as needed. • Responsible in submission activities for new product approvals and maintenance of market products, and include lead for pre－submissions, premarket approvals （PMAs）, reliability submission etc. • Ensure alignment of regulatory strategy and input on risk and benefit of potential plans • Lead communication with PMDA/MHLW to effectively bring submission/approval within expected timeline • Coach and manage RA subordinates |
| 応募資格 |
【必須（MUST）】 • Familiar with regulatory issues and challenges associated with IVD, CGP, CDx and medical device development.• Experience of leading and maintaining product approvals and change control. • Negotiation to PMDA/MHLW to effectively bring submission/approval within timelines. • Able to use Fluent Japanese and Business English to work with international colleagues. |
| 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 | 2024/08/21 |
| 求人番号 | 3793559 |
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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