Regulatory Affairs Manager (Tokyo, Japan)

Job Description

Regulatory Affairs Manager – Supporting Business Growth in the Japanese Market

Location: Tokyo, Japan
Posted on: November 21, 2025
Employment Type: Full-Time
Company: Confidential (via Cornerstone Recruitment Japan K.K.)
Industry: Medical / Pharmaceutical / Bio / Fabric / Food – Valuation/Testing, QA/QC

Job Description

The Regulatory Affairs Manager will play a vital role in supporting business expansion in Japan from a regulatory perspective. Collaborates with QA and Marketing to develop smooth transition processes and manage the future product portfolio strategy.

Key Responsibilities:

• Develop and implement submission strategies
• Review documentation for submission eligibility
• Lead interactions with PMDA and MHLW
• Maintain strong relationships with regulatory authorities
• Monitor and report on regulatory changes
• Prepare and file regulatory reports and responses
• Support inspections and audits from a regulatory perspective
• Manage regulatory aspects of product recalls
• Evaluate external regulatory communications
• Provide internal regulatory guidance
• Conduct training on regulatory compliance
• Represent the company in industry and regulatory meetings

Requirements

• Deep knowledge of Japan’s regulatory system
• Proven record in regulatory strategy and submissions for medical devices
• Connections with PMDA and MHLW
• Hands-on experience in submission processes
• Collaboration with global teams
• Experience with Sales, QA, R&D, and Marketing
• Strategic and business planning capabilities
• Prior experience with Class III devices preferred

Education:

• Bachelor’s degree in pharmacy, biomedical sciences, or technical discipline
• Advanced degree preferred
• Certified safety controller

Skills & Competencies:

• Proficient in English and Japanese
• Strong communication and stakeholder skills
• Start-up mentality and adaptability
• Problem-solving mindset
• Collaboration and conflict resolution abilities
• Detail-oriented and compliance-focused

Working Hours

Standard business hours

Compensation

Based on experience

Language Requirements

• English: Daily conversation level (TOEIC 475–730)
• Japanese: Native-level

Company Information

A global leader in insulin delivery solutions and diabetes management, operating in over 100 countries. Specializes in Class II and III medical devices, including insulin syringes and pen needles.