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| 部署・役職名 | Clinical Regulatory Affairs Specialist |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
About the role/ Responsibilities Perform the following major regulatory activities as directed. － Obtain approval/certification or submit notifications for pharmaceuticals, quasi－drugs, and medical devices in accordance with the PMD Act and other relevant regulations and contribute to the expansion of the product portfolio. － Contribute to the maintenance of business through renewal and management of various business licenses and regulatory review of external documents. Key activities: Perform the following tasks as the primary leader as directed. － Planning of regulatory strategy － Regulatory submissions （notification, certification, and approval） － Consultation and negotiation with Japanese authorities （MHLW, PMDA, and the prefectural governments, etc.） － Regulatory assessment for change control/ management － Support for new product and new business development from the RA perspectives － Attendance of trade association activities, and regional/ global regulations updates － Regulatory review of promotional materials － Regulatory review of packaging, labeling, package insert, and IFU, etc. － QMS submission and foreign manufacturing registration － Renewal and maintenance of business licenses （pharmaceuticals, quasi drugs, and medical devices） － Document control and information disclosure － Development and operation of quality management system in regulatory affairs － Regulatory intelligence － Clinical development operations such as project lead, progress management, and CRO management for clinical trials － Correspondence with Japan authorities related to clinical trials （submission of clinical trial notification, etc.） － Knowledge on regulatory requirements and close relationship with Japan Authority. － Communication of regulatory requirements and project status with internal stakeholders as necessary. |
| 応募資格 |
【必須（MUST）】 － Japan regulation knowledge management, not only PAL but also ISO, IEC, and other related international regulations etc.－ Scientific and clinical knowledge management to understand technical documents and academic articles, etc. － Good oral and written communication skill （Both Japanese and English） － Business level of proficiency in English 【歓迎（WANT）】 － BA/BS degree in a technical or scientific discipline such as biology, chemistry, physiology, pharmacology, engineering, medical or law. An advanced degree or additional professional training is preferred.－ A license of Pharmacist is desirable. |
| リモートワーク | 不可 |
| 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 | 2024/01/09 |
| 求人番号 | 3202671 |
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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