Position : Regulatory Affairs Manager, Japan
Reports to : General Manager
Location : Tokyo, Japan
Purpose
This role, reporting to the General Manager, is responsible for defining and executing the regulatory strategy for Japan. It involves overseeing product registrations and maintenance, supporting regulatory requirements for new product launches, and ensuring compliance with local regulations. The role also encompasses Safety Management (Pharmacovigilance), Medical Compliance, and providing related support to drive business success in Japan.
Key Responsibilities
The role includes the following core areas of responsibility :
1. Regulatory Affairs
- Manage new product submissions, maintain existing product registrations, address recalls and complaints, and navigate general regulatory policies.
- Develop and execute strategies for obtaining regulatory approvals, including submission planning and monitoring.
- Prepare import / reimbursement applications and maintain relevant documentation.
- Support product lifecycle management through regulatory submissions and variations to maintain compliance.
2. Safety Control & Pharmacovigilance
Establish and maintain a post-marketing safety system compliant with local regulations.Supervise safety surveillance and ensure timely reporting of adverse events to regulatory authorities.Develop and update SOPs, manage safety documents (e.g., J-RMP), and oversee regulatory communication on post-marketing safety matters.Ensure readiness for audits and inspections, providing training and support for safety management teams.3. Medical Compliance and Support
Provide accurate medical information for existing products to internal and external stakeholders.Review promotional materials to ensure compliance with regulations and codes.Address product complaints, adverse event reports, and medical inquiries.Collaborate on new product development, claims substantiation, and market strategies.Other Responsibilities
Support global and local teams as required.Undertake additional ad-hoc or cross-functional projects to meet business needs.Requirements
Qualifications
Bachelor’s degree required; a pharmacist license is advantageous but not mandatory.At least 8 years of experience in Japan’s pharmaceutical industry, with 6+ years in Regulatory Affairs and 3+ years in Safety Management or equivalent experience.Broad understanding of regulatory operations, including quality assurance, safety, and compliance.Skills & Experience
Strong knowledge of regulatory requirements for pharmaceuticals, medical devices, and related products.Experience with regulatory, clinical, and compliance matters across diverse healthcare products.Excellent project management and organizational skills, with the ability to handle multiple tasks and priorities.Strong interpersonal and communication skills to influence and collaborate with multiple stakeholders.Leadership capabilities with a hands-on approach to decision-making and problem-solving.Fluency in Japanese (native level) and English (business level).Personal Attributes
Adaptable and capable of working in a dynamic, fast-paced environment.Strong attention to detail, organizational skills, and follow-through.Positive, proactive attitude with a commitment to learning and development.Proven ability to work effectively within teams and establish strong relationships.High proficiency in IT tools and systems.