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。
•バイオワクチン課長を補佐し、課員業務の進捗確認及びレビュー、並びにリソース管理を行う。
•若手スタッフの指導、育成、及びコーチングを行う。
•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.
•Support a manager of Biologics & Vaccine products group, check and review the status of group members’ tasks, and control resource.
•Lead, develop and coach younger group members.
Requirements
必要:
•バイオ医薬品又はワクチンのCMC薬事担当者として5年以上の開発経験
•品質相談資料作成及び相談時の当局対応経験
•CTD及び承認申請書の作成、回答作成及び審査時の当局対応経験
•CMCに関する薬事知識(ICH、生物由来原料基準等)及び薬事一般の基礎知識(医薬品ライフサイクルマネジメント等)
•海外とのコミュニケーション経験
•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、英語プレゼン、及び英語文書作成能力(TOEIC800以上)
•Eメ-ル、Word、Excel、Power Point、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
望ましい資格:
•リーダー又はマネジャーとして部下を指導/管理した経験
•CMCラボ・パイロットでの実務経験
Required Qualifications:
•At least 5 years of Biologics or Vaccine products development experience in CMC Regulatory Affairs.
•Experienced in preparing PMDA consultation documents and dealing with issues.
•Experienced in preparing CTD and application form for approval, responding to inquiries on PMDA review and discussing with PMDA.
•Knowledge on CMC regulations (ICH Guidelines, Standards for biological materials, etc.) and basic knowledge on general pharmaceutical affairs (product life cycle management, etc.).
•Experience of commutation with overseas
•Master’s degree or above, in medicine, pharmacy, chemistry, or biology.
•Practical English speaking ability, presentation skills in English, and English documentation skills (TOEIC score 800 and over).
•Practical skills in E-mails, Word, Excel, Power Point, Acrobat.
•High level of compliance awareness.
Desired Qualifications:
•Experience of coaching/supervising group members as a manager or Leader
•Experience at CMC labs or pilot facility.
About interview
Liaison
Sr Scientist or Principal Scientist
RGF HR Agent
650 〜 1500 ten thousand JPY