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  3. Sr Manager, Regulatory Affairs(CAR-T)

Sr Manager, Regulatory Affairs(CAR-T)

1400 〜 1600 ten thousand JPY

  • RGF HR Agent
  • Location: Tokyo
  • Japanese level:None(+Studying) │Required length of experience:Uncategorized
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Date:2019/02/08~2019/08/08

Job summary

Job category Technical (Sales / Design / Development / Production Control)/Development / Research / Experimentation / Project Manager
Industry Health Care/ Other Health Care
Employment type Uncategorized
Position level Other
Number of openings 1
Desired entry time -
Required language skill

English (Fluent)

Foreign language competence -
Working hours Others
Welfares / Leave systems
Assistance in visa application -
Number of foreign employees -

Work details

Company Overview
血液がん・免疫に強み/高年収/ランキング15位以内

Job Description
- Work with submission team in Japan and Global to implement Japan regulatory strategy plans for both investigational and marketed products
- Participate in or lead Japan submission team and relating sub-team (project team) for assigned product(s) / project(s)
- Create, lead and review major regulatory applications (eg. CTNs, Briefing Documents for PMDA consultation, Orphan Drug Applications, Marketing Approval Applications, etc.)
- Participate in and/or lead regulatory interactions with MHLW/PMDA on assigned projects.
- Participate or acts as regulatory representative on various cross-functional teams
- Participate in cross-functional initiatives
- Maintain and reinforces compliance with Company SOPs and Work practices
- Provide input and comments on draft regulatory guidance

Requirements
- Bachelors degree in scientific discipline; Advanced scientific degree preferred.
- More than 10 years pharmaceutical industry experience.
- Thorough knowledge of the Japanese drug development process, CTN, PMDA consultation, NDA and NHI pricing process.
- Demonstrated experience in preparing Japan submissions.
- Good Understanding of the drug development process.
- Specific expert knowledge in one or more key areas expected: Oncology or Regenerative Products Development / CMC / PK / Clinical / Promotional
- Interdependent partnering skills, team-orientated with the ability to influence outcomes are necessary skills in the environment.
- Communication skill in English
- Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
- Must be able to innovate, analyze and solve problems with minimal supervision and maximum attention to detail
- Domestic and occasional International travel may be necessary

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Name of person in charge of hiring:

Sr Manager, Regulatory Affairs(CAR-T)

RGF HR Agent

1400 〜 1600 ten thousand JPY

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Company overview

RGF HR AgentSr Manager, Regulatory Affairs(CAR-T) RGF HR AgentSr Manager, Regulatory Affairs(CAR-T)

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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