Regulatory Affairs Manager at Top Global Bio-Pharmaceuticals

Tokyo 23 Wards Permanent ¥10,000,000 - ¥14,000,000 Foreign Multinational
  • Be part of one of the top global pharmaceutical companies in the industry
  • Lead the RA team developing, manage, and executing of all regulatory documents

About Our Client

  • One of the top global pharmaceutical companies in the industry
  • Innovative and progressive products and therapies for unmet medical needs
  • Rich pipeline within oncology, immunology, immuno-oncology, etc
  • Customer and employee centric foundation that prides in high quality culture

Job Description

  • Lead the RA team and be the representative of regulatory strategies
  • Create Japan focused regulatory section in the submission planning, management, and execution for all regulatory documentation ex. PMDA consultation, CTN and CTD documents, etc.
  • Review and provide regulatory input
  • Manage CRO regulatory activities
  • Review and consult appropriate regulatory promotion materials

The Successful Applicant

  • At least 5 years experience in regulatory affairs in the pharmaceutical industry
  • Experience in the development and management of regulatory strategies
  • Collaboration with global stakeholders throughout development and submission
  • High fluency in English and Japanese



What's on Offer

  • Competitive salary and benefits
  • Great work life balance
  • International working environment
  • Amazing career progression in regulatory affairs
  • Work with key industry individuals solving unmet medical needs
Contact
Zach Itozu
Quote job ref
4210922
Phone number
+813 6832 8683

Job summary

Function
Specialisation
Location
Job Type
Consultant name
Zach Itozu
Consultant phone
+813 6832 8683
Job Reference
4210922
Company Type