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  3. Sr Scientist or Principal Scientist

Sr Scientist or Principal Scientist

650 〜 1500 ten thousand JPY

  • RGF HR Agent
  • Location: Tokyo
  • Japanese level:Fluent │Required length of experience:Uncategorized
  • Close
Date:2019/02/08~2019/08/08

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

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Name of person in charge of hiring:

Sr Scientist or Principal Scientist

RGF HR Agent

650 〜 1500 ten thousand JPY

Close

Company overview

RGF HR AgentSr Scientist or Principal Scientist RGF HR AgentSr Scientist or Principal Scientist

RGF HR Agent

Human Resources / Education / Consulting / Professional Services /Staffing / Recruiting

RGF (Recruit Global Family) is the overseas corporation of Recruit Holdings Co., Ltd., Japan's largest talent comprehensive service and information service group enterprise, has started for more than 50 years, based on excellent business philosophy and management experience. Transcend national borders, we will discover new opportunities and possibilities worldwide.
RGF HR Agent provides solid support for the hiring activities of companies and the job-hunting activities of applicants as a general HR service company.
We provide not only regular recruitment but also RPO (Recruitment Process Outsourcing), contracts and so on. We deliver comprehensive services that could only be offered by RECRUIT=RGF, which is number one in Japan in the field of talent introduction, temporary staffing and recruitment information advertising. Having thoroughly met the needs of leading companies in Japan, we will also provide our consummate, high-quality services overseas. RECRUIT=RGF, which is number one in Japan, will continue taking on the challenge of becoming number one in the world.

JAPAN: RGF HR Agent Japan (CDS)
Address: 東京都渋谷区広尾1-13-7恵比寿イーストビル2F
TEL (+81)3-6422-4400
Website: http://www.rgf-hragent.asia/en/japan

CHINA: RGF HR Agent (Shanghai)
Address: 上海市淮海中路8号 蘭生大厦9F
TEL (+86) 21 5331 8000
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Suzhou)
Address: 蘇州市工業園区蘇州大道西1号 世紀金融大厦1615室
TEL (+86) 512 6262 3595
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Beijing)
Address: 北京市朝陽区東三環中路39号建外SOHO,A座902室
TEL (+86) 10 5869 0121
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Tianjin)
Address: 天津市和平区南京路189号津汇広場一号楼1106单元
TEL (+86) 22 2331 1169
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Dalian)
Address: 大连市高新技术产业园区黄浦路537号(七贤路)泰德大厦811室
TEL (+86) 411 8445 7095
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Guangzhou)
Address: 广州市天河区林和西路161号 中泰国际广场A塔1309室
TEL (+86) 20 8527 4585
Website: http://www.rgf-hragent.asia/china

CHINA: RGF HR Agent (Shenzhen)
Address: 深圳市罗湖区嘉宾路2018号深华商业大厦2507室
TEL (+86) 755 8237 5208
Website: http://www.rgf-hragent.asia/china

HONGKONG: RGF HR Agent Hong Kong Limited
Address: Unit 2206, 22/F, Wu Chung House, 213 Queen’s Road East, Wan Chai, Hong Kong
TEL (+852) 2537 2557
Website: http://www.rgf-hragent.asia/en/hongkong

VIETNAM: RGF HR Agent Vietnam Co., Ltd.
Address: RM903 Central Plaza 17 Le Duan St., Dist 1 Ho Chi Minh City
TEL (+84) 8 3911 5800
Website: http://www.rgf-hragent.asia/en/vietnam

THAILAND: RGF HR Agent Recruitment (Thailand) Co., Ltd.
Address: 689 BHIRAJ TOWER at EmQuartier, 23rd Floor, Room No. 2304-2306 Sukhumvit Road, North Klongton Sub-District, Vadhana District, Bangkok 10110
TEL (+66)2-021-0333
Website: http://www.rgf-hragent.asia/thailand/

SINGAPORE: RGF HR Agent Singapore Pte. Ltd.
Address: 71 Robinson Road #05-04 Singapore 068895
TEL (+65) 6221 7437
Website: http://www.rgf-hr.com.sg/

INDIA: RGF Select India Private Limited
Address: 704-705-706, 7th Floor, Vatika City Point, MGRoad, Gurgaon 122002
TEL (+91)124 4139711
Website: http://www.rgf-hragent.asia/en/india

INDONESIA: PT. RGF Human Resources Agent Indonesia
Address: Jakarta Office: Graha Pratama, P1F (21F), Jl. M.T.Haryono Kav. 15, Jakarta 12810, Indonesia
TEL (+62) 21 8378 2866
Website: http://www.rgf-hragent.asia/en/indonesia

Company profile

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