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

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.

Client Details

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.

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

Job 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)

To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Sobi Tantisakchaichan on +81357337165.

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