Regulatory Affairs Manager at Top Global CRO

Tokyo 23 Wards Permanent ¥8,000,000 - ¥15,000,000 Foreign Multinational
  • Take lead in the pharmaceutical affairs of ICCC studies and examination
  • Be part of one of the leading global CRO's who are solving unmet medical demand

About Our Client

  • One of the largest global CRO in the industry
  • Operating in over 100 countries worldwide with 70,000 experts executing efficient and progressive clinical trials
  • Primarily focused phase I-IV clinical trials and provides laboratory, analytical, consulting, services
  • Works within all therapeutic areas including the recent COVID-19 pandemic
  • Progressive and innovative practices providing an employee/customer centric focus

Job Description

  • Be the leader in pharmaceutical affairs for ICCC studies and the point of contact for examination
  • Provide efficient regulatory judgement and advice for internal and external inquires
  • PMDA support after submissions as well as any consultation regarding to problems during clinical trial period
  • Create and review SOP's
  • Work with cross functional teams providing regulatory advice when necessary

The Successful Applicant

  • Experience as a pharmaceutical manager
  • Experience in handling MHLW/PMDA inquiries
  • High fluency in English and Japanese
  • Knowledge of related regulations (GCP,GMP,etc)

What's on Offer

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

Job summary

Job Type
Consultant name
Zach Itozu
Consultant phone
+813 6832 8683
Job Reference
Company Type