Job summary
| Job category | Technical (Sales / Design / Development / Production Control)／Production Control / Quality Control / Construction Control / Environment, Health, and Safety / Postmarketing Surveillance |
|---|---|
| Industry | Health Care／ Other Health Care |
| Employment type | Uncategorized |
| Position level | Other |
| Number of openings | 1 |
| Desired entry time | - |
| Required language skill |
English （Business） Japanese （Fluent） |
| Foreign language competence | - |
| Working hours | Others |
| Welfares / Leave systems | |
| Assistance in visa application | - |
| Number of foreign employees | - |
Work details
Company Overview
大手外資製薬メーカー/オンコロジー領域へ注力/福利厚生充実
Job Description
•本社等のCMC薬事担当者と協働し、担当品のCMC開発ステージを適正に前進させ、論理的で科学的に質の高い承認申請資料のCMCパート（製造方法、規格及び試験方法、並びに安定性等）を作成する。
•製品に関するCMC上の問題点の抽出及びリスク評価、並びにその対応策の作成を行う。
•規制当局又は業界団体より入手したCMC薬事情報を国内・海外関連部門へ提供し、協議を行う。
•CMCに係わる変更情報を評価し、必要に応じ適切に薬事対応を行う。
•当局相談あるいは承認審査において、適切に照会対応を行い、必要に応じて交渉を行う。
•海外出張や電話会議において、本社又は海外サイトの関係者と連携し、CMC関連事項の戦略的対応策を作成する。
•Collaborate with HQ CMC RA members to appropriately advance the CMC development stage of the project in charge, and prepare CTD CMC parts (i.e. Manufacturing method, Specifications and test methods, and Stability) logically with high scientific quality.
•Identify product issues and assess risks from the CMC viewpoint, and plan countermeasures.
•Provide CMC-RA information obtained from regulatory authorities or industry associations to Japan/overseas relevant divisions, and discuss with them.
•Evaluate CMC related changes and take appropriate RA action, if necessary.
•Appropriately respond to questions from the authorities on consultations or on review for approval, or negotiate if necessary.
•Cooperate with HQ or overseas sites through overseas business trips or teleconference to prepare the strategic countermeasures on CMC relating matters.
Requirements
必要:
•CMCラボ・パイロットでの原薬・製剤又は分析の実務経験、あるいはCMC薬事実務経験
•医学、薬学、化学、生物学等の修士卒以上
•実務レベルの英会話能力（TOEIC750以上）
•Eメ－ル、Word、Excel、PowerPoint、Acrobatについて、実務レベルの能力
•高いコンプライアンス意識を有する
•協調性があり、自発的動機づけができ、根気よく課題や問題に取り組む
望ましい資質:
•海外とのコミュニケーション経験
Required:
•Experience at CMC labs or pilot facility of Drug Substances/Drug Products, or Analyses, or CMC Regulatory Affairs.
•Master’s degree or above, in medicine, pharmacy, chemistry, or biology.
•Practical English speaking ability (TOEIC score 750 and over）.
•Practical skills in E-mails, Word, Excel, PowerPoint, Acrobat.
•High level of compliance awareness.
•A person cooperative, voluntary motivated, and patiently challenge the issues toward solution.
Desired Qualifications:
•Experience of overseas communication
About interview
Liaison
CMC Scientist
RGF HR Agent
450 〜 830 ten thousand JPY
