CMC薬事Manager ー 外資系製薬メーカー

勤務地 Tokyo, Japan
職種 正社員
給与 ¥9000000.00 - ¥11000000.00 per annum
専門 ライフサイエンス(医療機器・製薬・化学・ヘルスケア・農業・畜産),
Sub-specialization 薬事,
お問合せ Yuichi Matsuda
参照 JO-2001-433963
about Yuichi Matsuda

[Company Description]
Global Software Company

[Responsibilities]
Provide high quality and robust CMC regulatory strategies and documents to support business needs in development and post market maintenance.
a. CTD module 3 in collaboration with global RegCMC
b. QOS (module 2)
c. Application Form

[Requirements]

  • University degree or equivalent (Preferred education: Biochemistry, Genetic engineering, Cell and molecular biology, Immunology, Chemical synthesis, Analytical Chemistry)
  • Fluent English as business language
  • Over 3-years experience in CMC related business area

[Preferred Knowledge, Skills and Abilities]

  • Experience of development, manufacturing, analytical testing and/or CMC regulatory for biologics products such as antibody drugs
  • Experience of research, development and/or manufacturing for regenerative medicine especially for cell and gene therapies.

[Employment Type]
Full time

[Salary]
9 Million 〜 11 Million Yen
(Experiences and skills will be considered)

[Location]
Tokyo

[Welfare]
Social insurance

[Holidays]
Full 2 holiday week system (Sat/Sun) national holidays
New year's holiday
Annual Leave


Please click "apply" if you are interested in the job.