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| 部署・役職名 | CMC Regulatory Science Expert / Non Line Manager / Reculatory Science Expert Group CMC Dept |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
【Basic Purpose of the job】 This position is responsible for preparing and reviewing CMC relevant documents as well as assessing and mitigating risks on clinical trials and NDA in Japan for New Molecular Entity projects in accordance to all applicable latest regulatory requirements and science （ICH, cGMP, SOPs, etc.） as well as in a proactive collaboration and coordination with BI partners. 【Accountabilities － Related Performance Indicators】 Author and review all the CMC relevant documents for regulatory submission （e.g. CTD, IB, etc） in accordance to all applicable guidelines and regulations （ICH, cGMP, SOPs, etc.） as well as the state of the art science －Author and review the Common Technical Document （CTD）, I.B. for quality section, quality consultation materials and CMC documents for CTN based on state－of－the－art regulatory requirements and scientific knowledge/experiences －Review the key CMC documents （e.g. IF, PI etc）. －Interact with RA and D＆D team on content and format of CMC documents －Author JAN application document Supervise/discuss with project teams from CMC aspects in preparing any clinical study plans and regulatory relevant documents in accordance to all applicable guidelines and regulations （ICH, cGMP, SOPs, etc.） in view of future submission in Japan －Proactively assess risks on future submission in Japan for all development projects －Discuss with project teams to prepare regulatory relevant documents as well as development strategy in Japan －Provide project teams with guidance in preparing any study plans, especially Bioequivalency study, in a way to enable successful clinical trials and regulatory submission in Japan. －Contribute to establishing proactive response strategies Interface to regulatory agencies （e.g., PMDA） based on the global strategy －Interact with local regulatory bodies during the development （e.g, pre－NDA meetings, formal and informal discussions, etc.）, submission and review －Prepare responses to PMDA inquiries in alignment with global CMC consultancy team and SME －For end of J－NDA review, update J－QOS, review PMDA's review reports and prepare masking of disclosure documents. －Prepare data integrity inspection with QA and global SME. －For clinical development/CTN, reflect PMDA's opinion into development strategy （e.g. formulation bridging, etc.） or relevant documents （e.g. CTN, Cartagena application） Support product launch and customers －Provide additional CMC information （e.g. in－use stability/compatibility data, scientific explanation） of the products to the relevant functions and customers as requested Support internal and external innovations －Support internal and external innovations in KPRI by providing expertise and networks Support to develop expertise, know－how and competency of group members －Coach staffs to acquire skills, help them solve problems and develop their career plans Interfaces: －Global R＆D team, CMC－consultancy team, Global CMC experts NCE/NBE －Local RA, Local CMC－RA, Local Project Team （Evidence team and Value team） |
| 労働条件 |
契約期間：期間の定めなし 試用期間：あり（3カ月） 就業時間：8:45～17:20（うち休憩45分間） 休日：土日、祝日 その他各種会社休日あり（年間127日：2025年） 休暇：年次有給休暇（入社初日に6～16日を付与）、慶弔休暇・リフレッシュ休暇等各種有休特別休暇制度あり 残業：あり 給与改定：年1回（4月） 通勤手当：会社規定に基づき支給 社会保険：健康保険、厚生年金、労災保険、雇用保険 |
| 応募資格 |
【必須（MUST）】 Required Education:Masters Degree eg MBA or MSc 博士修了 Chemistry 化学 Required Capabilities （Skills, Experiences, Competencies）: Required Skills: ・Special Skills: －Sufficient knowledge of the drug development for CMC part －Developing submission strategy in Japan in accordance with Japanese drug regulations based upon scientific rationale ・Language Skills ＆ Proficiency: －Japanese: Native/Fluent －English: Excellent oral and written presentation skills in English required Requires Experience: ・Leading projects ・International Experience: －Int'l exposure in daily business （>50％of international business / customers / staff） （1.5 － 4 years～） ・Special Work Experience －7－10 years of experience in an international or local pharmaceutical R＆D organization －Strong CMC background with proven performance record （not less than 3 projects） －International work experience （cross－cultural competence） 【歓迎（WANT）】 －One or multiple extended business trips （up to 6months） abroad－Work abroad （1.5 years～） |
| 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 | 2026/02/24 |
| 求人番号 | 7560804 |
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