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Job Types > Regulatory Affairs

Regulatory Affairs

Job Overview

We are involved in the design and development of instruments and reagents. We also handle regulatory applications to gain regulatory affairs approval from each countries' regulatory authorities such as the Ministry of Health, Labor, and Welfare.

Job Description

  • Research product design processes from a regulatory perspective and share the information with others
  • Applications for regulatory approval to the Ministry of Health, Labor and Welfare, the FDA (US), etc.

* Applications for regulatory approval: to apply the pharmaceuticals, medical devices, cosmetics, etc. to regulatory authorities around the world, (in Japan, the regulatory authority is the Ministry of Health, Labor, and Welfare) for sale and use approval.
*It is a highly specialized position that conducts research activities to obtain approval and licenses for Sysmex products to be sold globally from regulatory authorities in various countries and gain approval.

Potential assignments

  • Regulatory Affairs & Quality Assurance
  • Medical Affairs

Recommended for:

  • Individuals who wish to have a professional career in Regulatory Affairs in a global company
  • Individuals who want to gain a holistic view of the company by cooperating with many divisions and overseas affiliate companies
  • Individuals who want to make use of their pharmaceutical knowledge or qualifications as a pharmacist

Relevant Majors

Mechanical Engineering, Mathematics, Electrical and Electronic Engineering, Information Technology, Physics and Applied Physics, Biology and Life Sciences, Chemical and Materials Engineering, Natural Resources and Global Environment, Agriculture and Agricultural Sciences, Pharmaceutical Sciences (4-year course), Pharmaceutical Sciences (6-year course), Medicine and Dentistry, Veterinary Medicine, Hygiene and Medical Care, other Sciences

Law and Policy Studies, Economics, Management and Commerce, Social and Environmental Information Studies, Foreign Languages and International Culture, Humanities, Education, Life Sciences, Medical and Health Sciences, other Humanities