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
| 部署・役職名 | Development Regulatory Affairs Manager |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Group Purpose: Facilitate patient access to company products in Japan through executing the development and regulatory plans; providing strategic regulatory expertise for drug development; interfacing with agencies on regulators; aligning with key cross－functional partners; integrating into the company’s commercialization process, and continuously improving our processes and developing our talent. Job Summary: － Conducts regulatory activities for company products in Japan － Support drug development or commercialization activities in Japan based on the regulatory and submission strategy by serving as Japan Regulatory Lead （JRL） － Develop and maintains good relationship with Japanese Health Authorities to facilitate drug approvals. － Provide regulatory guidance and supports various internal teams by involving Japan Development Team and Global Regulatory Team. Key Activities － Represent Japan at Global Regulatory Team as Japan Regulatory Lead （JPRL） and on various cross－functional teams, including Japan Project teams, Japan Development Team, etc. － Develop and implement Japan regulatory strategy for the projects in Japan, aligned with global regulatory strategy as much as possible. － Responsible of leading health authority interactions and the preparation of regulatory submissions, which may include New Drug Applications （NDAs）, Briefing Documents for various type of PMDA consultations, Clinical trial notifications （CTNs）, Package Insert and Orphan Drug Applications, etc. － Work cross－functionally with the various interanl teams related to NDAs, PMDA consultations and CTNs, etc. － Serve as the primary interface to Global regulatory lead and JAPAC Reginal regulatory lead of each product. － Responsible as the primary interface for MHLW and PMDA for product approval and clinical development. － Assemble and provide local regulatory input to a variety of local and global teams in a timely manner － Contribute to the development and maintenance of Regulatory Affairs working practices and procedures. － Execute and maintain compliance for all documents to be submitted to Health Authorities |
| 応募資格 |
【必須（MUST）】 Knowledge And Skills－ Over 10 years experiences in Research ＆ Development of pharmaceutical industry including at least 5 years experiences in regulatory affairs with experiences conducting PMDA consultations and CTN submission in Japan. － Work in matrix environments including global teams under global environment. － Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information. － Anticipates and prevents potential problems. Independently develops solutions that are thorough, practical and consistent with functional objectives － Work under minimal direction （with middle degree of autonomy） － Ability to understand scientific/clinical information － Organizational, communication and time management skills needed to manage multiple assignments and processes － Build good relationships with project team members and RA members － Communication skills in English － Native level Japanese － Computers: Microsoft Outlook/ Word/ Excel/Power Point Education / Experience Basic － Bachelors in scientific discipline; more than 10 years pharmaceutical industry with more than 5 years experiences in development regulatory affairs. 【歓迎（WANT）】 － More than 5 years experiences in development regulatory affairs working on oncology/hematology drugs.－ TOEIC score ≥780, desirable － Advanced degree preferred. |
| 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 | 2024/08/27 |
| 求人番号 | 3815338 |
採用企業情報
- 企業名は会員のみ表示されます
- 会社規模5001人以上
この求人の取り扱い担当者
-
- ?
- ヘッドハンターの氏名は会員のみ表示されます
会社名は会員のみ表示されます
-
- メーカー メディカル
-
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