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Updated 2020-11-15
Activated 2020-11-15

CMC Pharmaceutical Affairs Jobs: Major Pharmaceutical Manufacturer

  • ★★ Staff Level
  • Women Welcome
  • New graduates welcome
  • Listed Public Company
  • No Experience Required
This posting is managed by:
Recruiter
j Career Co.,Ltd. / 株式会社 j Career
Company Name Company is not publicly visible
Job Type
j Career Co.,Ltd. / 株式会社 j Career
Medical/Pharmaceutical/Bio/Fabric/Food - Patent
Medical/Pharmaceutical/Bio/Fabric/Food - QA/QC
Medical/Pharmaceutical/Bio/Fabric/Food - Other
Industry Pharmaceuticals
Location Asia Japan Tokyo Chiyoda
Asia Japan Tokushima
Job Description 1. Regulatory investigation work in each country
2. Coordinate with overseas sales companies and our subsidiaries to formulate pharmaceutical affairs strategies, application for approval and maintenance after sales
Business to lead internal departments together according to the Pharmaceutical Affairs Strategy formulated in 3.2
Company Info We are energetically promoting research and development of highly novel medicines such as anti-cancer agents, immune/allergy, and urological medicines. In particular, in recent years, in order to quickly deliver our own drugs to patients around the world and to maintain their quality, we have established a global pharmaceutical affairs strategy and are applying, approving, and maintaining drugs.

In order to further promote globalization, we are looking for a person who can cooperate with overseas sales companies and subsidiaries to carry out new drug application and maintenance related operations (CMC) after approval.

[Measures to prevent second-hand smoke]
Indoor smoking ban (with smoking room)
Working Hours Working hours: 8:30 to 17:30 (head office), 8:00 to 17:00 (Tokushima)
Break time: 12:00~13:00
Job
Requirements
[Required]
・Experience in overseas application/approval such as US and EU in CMC related departments
・Person with basic knowledge related to CMC (GMP, DMF, analysis, manufacturing, etc.)

【welcome】
・English communication ability to exchange opinions with overseas regulatory officers
・M1, M2.3, M3 writing experience

[Preferable figure]
・Person who has interpersonal coordination and can build a relationship that can cooperate with internal and external parties
・Those who are willing to work actively, make their own decisions, and work with others
・A person who can make positive proposals based on logical thinking about future strategies for solutions when analyzing problems and seeking solutions.
・Those who are willing to take on challenges and have the ability to respond to new or sudden changes in the work environment
・Those who are tenacious and can work hard to accomplish even in tasks that require detailed and time-consuming work
Japanese Level Business Level(JLPT Level 2 or N2)
Salary JPY - Japanese Yen JPY 4000K - JPY 5000K   
Other Salary
Description
Basic salary 300,000 to 350,000 yen/month, with bonus

Employment insurance, industrial accident insurance, employee pension, health insurance
Holidays Sundays, public holidays, year-end and New Year holidays, company-designated holidays
Job Contract
Period
Contract period: 6 months or 1 year (after that, it is assumed that full-time employees will be appointed)
Trial period: None
Nearest Station Tokyo (head office) or Tokushima City

◆ Tokyo (head office)
・Ogawamachi/Awajicho Station
・Kanda Station
・Otemachi Station

◆ Tokushima City
・From Tokushima Airport
8 minutes by bus, 10 minutes on foot
・From Tokushima Station
15 minutes by bus, 10 minutes on foot
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j Career Co.,Ltd. / 株式会社 j Career

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CMC Pharmaceutical Affairs Jobs: Major Pharmaceutical Manufacturer

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