The Opportunity:

As a member of the Regulatory Affairs organization, you will play a critical role in advancing innovative oncology therapies from development through registration and commercialization, helping bring transformative medicines to patients worldwide.

The Associate Director, Regulatory Affairs Japan will serve as the regulatory lead for assigned development programs and products in Japan. This individual will be responsible for developing and executing regulatory strategies to support clinical development, registration, and lifecycle management activities. The role will represent Japan Regulatory Affairs on global project teams, contribute to PMDA interactions, and provide strategic regulatory guidance to support successful development and commercialization activities in Japan.

Key Responsibilities

Regulatory Strategy Leadership

• Lead regulatory activities for assigned programs and products in Japan.

• Develop and execute regulatory strategies supporting clinical development, registration, and lifecycle management.

• Conduct regulatory assessments and provide recommendations for development programs.

• Identify regulatory risks and develop mitigation plans.

• Provide regulatory guidance to cross-functional teams.

Health Authority Leadership

• Lead PMDA consultations and routine regulatory interactions with appropriate management support.

• Prepare briefing packages, meeting materials, and responses to health authority inquiries.

• Lead or support J-NDA submissions and post-approval activities.

• Ensure alignment of Japanese regulatory requirements with global development plans.

Global and Cross-Functional Collaboration

• Represent Japan Regulatory Affairs on global project teams.

• Collaborate with Clinical Development, Clinical Operations, Medical Affairs, Safety, CMC, Quality, and Medical Writing functions.

• Contribute to project decision-making and regulatory planning.

Vendor and CRO Management

• Manage regulatory consultants, vendors, and CRO partners supporting Japan activities.

• Monitor timelines, deliverables, budgets, and quality of outsourced work.

People Leadership

• Mentor junior regulatory colleagues and contribute to team development.

• May provide supervisory responsibilities for contractors or junior staff.

Required Skills, Experience and Education:

• Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related discipline; advanced degree preferred.

• Typically 8+ years of pharmaceutical or biotechnology industry experience, including significant Regulatory Affairs experience.

• Experience supporting regulatory strategy for clinical development and registration programs.

• Strong knowledge of Japanese pharmaceutical regulations, PMDA processes, and ICH guidelines.

• Excellent communication and collaboration skills.

Preferred Skills:

• Oncology drug development experience.

• PMDA consultation experience.

• Experience supporting NDA/J-NDA submissions.

• Experience working on global development programs.

• Experience managing vendors or CROs.

Leveling Considerations

Associate Director

• Independently leads regulatory activities for assigned programs.

• Provides strategic regulatory input and manages external partners.

• Leads PMDA interactions with appropriate support.

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