CMC Regulatory Staff or Manager at Global Pharma

Tokyo 23 Wards Permanent ¥7,000,000 - ¥12,000,000 Foreign Multinational
  • Be part of one of the top global pharmaceutical company in the industry
  • Build the CMC regulatory strategy for new drug applications

About Our Client

  • One of the top global pharmaceutical companies in the industry
  • Leading player in the R&D market with therapeutic areas including vaccines, consumer health care, respiratory, HIV, Oncology, etc
  • Innovative and progressive pipeline and projects solving various unmet medical needs

Job Description

  • Establish CMC regulatory strategy in order to gain appropriate CMC approval requirements for the procedure to obtain approval with the application for changes in ongoing processes
  • Make policy decisions in consideration for the approval period
  • Lead the coordination in inqueries of any process issues and collaboration with cross functioning departments as well as drive efficient results
  • Discuss with global stakeholders regarding CMC issues that arise with products
  • Propose strategies on behalf of CMC regulatory affairs

The Successful Applicant

  • High fluency in both English and Japanese is required
  • Background in analytic chemistry, organic chemistry, biology or pharmaceuticals
  • Experience in manufacturing method or GMP
  • Knowledge and experience in CMC related work (analysis, manufacturing, CMC regulatory affairs)

What's on Offer

  • Competitive salary and benefits
  • Great work life balance
  • International working environment
  • Amazing career progression
  • Work with industry leaders who are solving unmet medical needs
Contact
Zach Itozu
Quote job ref
4212452
Phone number
+813 6832 8683

Job summary

Function
Specialisation
Location
Job Type
Consultant name
Zach Itozu
Consultant phone
+813 6832 8683
Job Reference
4212452
Company Type