Director, Regulatory Affairs (upto 15M) - Fully Remote

• Join a global regulatory consultancy as their first permanent regulatory strategy lead in Japan. This senior role supports development-stage projects, PMDA interactions, and submission planning across multiple therapeutic areas.

Client Details

• Our client is a leading global provider of regulatory, clinical, and compliance services, supporting pharmaceutical and biotech companies worldwide. Known for its high-quality service and fully remote work culture, the organization offers strong career growth and meaningful global impact.

Description

• Lead Japan regulatory strategy for global drug development programs
• Manage PMDA consultations, CTNs, and registration submissions
• Act as Japan project lead and coordinate with global teams
• Align Japan regulatory plans with global development strategies
• Review English-language submissions for Japanese use
• Oversee local vendors and consultants to ensure delivery
• Stay current on regulatory changes and contribute to planning
• Represent the company in client meetings with strategic input

Job Offer

• Fully remote work
• English-using environment with global teams
• Competitive salary up to ¥15M total compensation
• High-impact role with international client exposure
• Opportunity to shape regulatory function in Japan

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:

• Regulatory or development experience focused on Japan
• Strong PMDA interaction experience (clinical & pre-market)
• Proven project leadership from early development to NDA
• Comfortable operating independently and cross-functionally
• Fluent in Japanese and English
• Consulting/CRO/global pharma background preferred
• Strategic, collaborative, and hands-on mindset