Description

You will lead global regulatory strategies and submissions for Rakuten Medical's oncology pipeline, ensuring compliance with international requirements and driving cross-functional collaboration to bring innovative therapies to patients.

Requirements

• Deep knowledge of global regulatory frameworks for biologics and combination products
• Proven experience leading regulatory submissions and strategies across regions
• Strong leadership and cross-functional collaboration skills
• Ability to assess regulatory risk and drive mitigation strategies
• Experience with regulatory systems and project management

Responsibilities

• Develop and execute integrated global regulatory strategies for drug and device programs
• Lead cross-functional teams to prepare high-quality regulatory submissions (IND/CTA through NDA/BLA)
• Oversee global regulatory authority meetings including briefing packages and negotiations
• Ensure compliance with global regulations (FDA, EMA, PMDA, etc.) and maintain documentation systems
• Manage regulatory project plans, timelines, and vendor relationships