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Director, Regulatory Affairs (Up to 25M JPY, including RSU)

Kanagawa 外資系企業 ¥20,000,000 - ¥25,000,000 per year Foreign Multinational Work from Home or Hybrid View Job Description
This leadership position directs the regulatory development department, ensuring successful drug approvals. You will oversee regulatory compliance and collaborate with global teams to guide the development process while managing regulatory strategy for various therapeutic areas.
  • Lead regulatory strategy for a global healthcare leader
  • Drive innovation in regulatory affairs with cross-functional teams

About Our Client

Our client is a global leader in healthcare innovation, with a strong focus on improving patient outcomes through groundbreaking drug and device solutions. They are expanding their team in Japan and are seeking a forward-thinking regulatory professional to lead their efforts in regulatory affairs, including supporting drug development and approvals.

Job Description

  • Supervise and guide Regulatory Compound Leaders to achieve successful drug approvals
  • Ensure compliance with relevant laws, regulations, and guidelines
  • Collaborate with Japanese Health Authorities and global regulatory affairs teams
  • Manage regulatory policy intelligence activities in Japan and represent the Regulatory Development Department in R&D governance
  • Prepare annual budgets, monitor expenditures, and manage resources for regulatory operations
  • Recruit, mentor, and retain a diverse team within RDD, promoting innovation and strategic thinking
  • Take responsibility for regulatory strategy across multiple products and portfolio issues

The Successful Applicant

A successful 'RA Director' should have:

  • Over 5 years of relevant regulatory affairs experience, including leadership roles
  • Strong background in regulatory compliance, CMC regulatory affairs, and marketed products
  • Proven leadership and management experience with a focus on innovation and process improvement
  • Master's degree or equivalent in a relevant field
  • Strong communication skills, fluent in both English and Japanese
  • Experience working with both Japanese Health Authorities and global teams

What's on Offer

  • Location: Tokyo, Japan
  • Reporting To: Senior Director of Regulatory Affairs Division
  • Salary: Up to 25M JPY (including RSUs)
  • Work Type: Hybrid (flexible work options)
Contact
Sobi Tantisakchaichan
Quote job ref
JN-042025-6718254
Phone number
+81357337165

Job summary

Function
Life Sciences
Specialisation
Regulatory Affairs
Specialisation
Healthcare / Pharmaceutical
Location
Kanagawa
Job Type
Permanent
Consultant name
Sobi Tantisakchaichan
Consultant phone
+81357337165
Job Reference
JN-042025-6718254
Company Type
Foreign Multinational
Work from Home
Work from Home or Hybrid

Diversity & Inclusion at Michael Page

We don't just accept difference - we celebrate it. We encourage applicants from all backgrounds to apply for this role and are committed to building inclusive, diverse workplaces where everyone can thrive. If you require any support or reasonable adjustments during the recruitment process, please let us know.