Lead regulatory strategy for Japan's pharmaceutical market. ICON is seeking a Senior Manager of Regulatory Affairs with deep expertise in PMDA submissions and Japanese regulatory requirements. In this hybrid role, you will develop strategic drug development plans, lead client engagements, and manage regulatory submissions while mentoring team members and driving business growth in the Japanese pharmaceutical market.
Key Responsibilities
You will serve as the regulatory expert for Japan, leading submissions and strategic consulting for pharmaceutical development.
Regulatory Strategy & Submissions:
- Lead PMDA interactions and negotiations, preparing meeting materials and regulatory submissions
- Develop comprehensive regulatory strategies for new drug applications from clinical trials to approval
- Conduct regulatory assessments and provide strategic input to global regulatory teams
- Prepare and review regulatory documents including clinical trial notifications and marketing authorization applications
Client Engagement & Business Development:
- Serve as trusted regulatory advisor to ICON clients, presenting regulatory strategies and solutions
- Represent Regulatory Affairs in business development activities to generate new opportunities
- Collaborate with global regulatory teams and clients on Japan-specific regulatory requirements
Team Leadership & Mentorship:
- Mentor and develop team members' regulatory skills and capabilities
- Provide regulatory guidance to cross-functional internal teams
- Supervise regulatory activities and ensure quality deliverables
Your Skills and Experience
Essential Qualifications:
- Minimum 7 years of regulatory affairs experience in pharmaceutical/CRO industry
- Proven experience in Japanese regulatory affairs including PMDA interactions
- Demonstrated expertise in regulatory strategy development and submission management
- Supervisory or team leadership experience
Required Expertise:
- Comprehensive knowledge of PMDA requirements and regulatory processes
- Experience with clinical trial applications and new drug submissions
- Strong English and Japanese communication skills (written and verbal)
- Excellent organizational, presentation, and problem-solving abilities
Why Join ICON?
Our success depends on our people. When you join ICON, you become part of a team dedicated to excellence in clinical development. We offer:
- Hybrid Flexibility: Remote/office hybrid work model in Tokyo/Osaka
- Competitive Salary and comprehensive benefits package
- Health Insurance and retirement planning options
- Global Employee Assistance Programme and extensive well-being support
- A diverse, inclusive culture that rewards high performance
Ready to lead regulatory strategy for Japan's pharmaceutical market? We encourage you to apply even if you don't meet every single requirement. Your expertise in Japanese regulatory affairs is highly valuable to our mission.
