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| 部署・役職名 | 【需要が高いTA領域・バイオ特化・外資バイオベンチャー】Regulatory Scientist |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
こんな方なら向いている ― グローバル及び日本で両方基盤がしかっりした外資バイオベンチャーにおいて申請業務をリードしたい方 ー バイオ製品に特化し、中枢神経系疾患及び免疫疾患領域での申請業務をやりたい方 ー 階級に厳しくなく、フラットな組織で幅広い守備範囲で業務に携わりたい方 Main Responsibilities: － Accountable for tasks as Japan Regulatory Scientist on assigned projects. Prepare and implement Japan RA strategic and operational plans for development products and LCM in line with global RA strategy with support from the Regulatory Science Lead. － Lead the delivery of timely regulatory approvals as a member of the Development/Submission team with the Regulatory Science Lead. － Lead the planning, preparation, and delivery of regulatory submissions and PMDA consultations with support from the Regulatory Science Lead. － Prepare and review regulatory submission documents, PMDA briefing documents, CTN documents, and response documents within agreed timelines. － Manage local e－CTD publishing processes for quality and on－time NDA submission. － Ensure the quality of regulatory documents in compliance with quality standards. － Provide regulatory expertise on regulatory submissions, applications, and regulatory document preparation to global and local development/submission teams, while liaising proactively with relevant functions. － Assume assigned responsibilities for routine and non－routine contact with PMDA and global counterparts. － Build effective relationships with regulatory agencies and external parties （PMDA/MHLW/Academia/Industry associations）. － Assist in the development of regulatory standards and SOPs. － Develop regulatory knowledge and behavior according to the Personal Development Plan. － Guide RA staff and support Japan Regulatory. － Appropriately use budgets of Japan Regulatory to meet objectives. |
| 応募資格 |
【必須（MUST）】 － Bachelor's Degree/Master’s Degree （preferable）.－ Thorough understanding of Japanese regulations and regulatory procedures. － Review skills for regulatory documents. － Ability to communicate and give presentations in English and Japanese. － Ability to manage and communicate well with other RA staff, other functions, and CROs. － Ability to build and manage effective relationships with regulatory agencies. － Flexibility and adaptability to decide actions based on the situation, change behavior or approach to fit the situation or the person, and work effectively in ambiguous situations. － Ability to lead an assigned cross－functional team to achieve key outcomes within agreed timelines. |
| 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 | 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 | 2024/12/09 |
| 求人番号 | 4143914 |
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