We use cookies to deliver our services. By visiting our website, you agree to the use of cookies as described in our
Privacy Policy
Daijob.com is Japan's definitive job site for multilingual professionals.
Job Search
Updated 2025-05-01
Activated 2025-05-01
Activated 2025-05-01
Regulatory Affairs Manager/Aiming for business growth in the Japanese market
| This posting is managed by: | Cornerstone Recruitment Japan K.K. |
|---|---|
| Company Name | Company is not publicly visible |
| Job Type |
 Medical/Pharmaceutical/Bio/Fabric/Food - QA/QC |
| Location |
Asia
Japan
Tokyo
|
| Job Description |
Summary The RA Manager will play a crucial role in supporting business growth in Japan from a regulatory affairs perspective. This position requires close collaboration with QA and Marketing to establish a seamless transition process while taking ownership of future portfolio strategy. Key Responsibilities • Develop and implement best-in-class submission strategies. • Assess the acceptability of quality, preclinical, and clinical documentation for submission filing. • Lead interactions and negotiations with PMDA and MHLW to ensure timely submission approvals. • Build and maintain positive relationships with regulatory authorities. • Monitor regulatory changes and assess their impact on submission strategies, updating internal stakeholders accordingly. • Prepare and submit required regulatory reports and responses. • Provide regulatory input and follow-up for inspections and audits. • Support regulatory aspects of product recalls and related communications. • Review and assess external regulatory documents and communications. • Advise internal stakeholders on regulatory issues and requirements. • Provide training on regulatory compliance, including safety-related operations. • Represent the company in industry meetings and regulatory discussions as needed. Experience • Extensive knowledge and experience with Japan’s regulatory landscape. • Expertise in developing Japan regulatory strategies and executing high-quality submissions for medical device registrations. • Established relationships with PMDA and MHLW. • Hands-on experience with regulatory submissions. • Strong collaboration with regional and global teams. • Experience working cross-functionally with Sales, Marketing, QA, R&D, and other key departments. • Strong strategic thinking and business planning mindset. • Experience with regulatory submissions and direct communication with PMDA. • Prior experience with Class 3 or higher medical devices is preferred. Education • Bachelor’s degree in pharmacy, biomedical sciences, or a technical discipline (e.g., biology, chemistry, engineering). • Advanced degree preferred. • Required qualification of safety controller. Skills & Competencies • Proficiency in both English and Japanese. • Strong communication and stakeholder management skills. • Adaptability and enthusiasm for working in a start-up environment. • Ability to navigate challenges and unprecedented issues proactively. • Collaborative mindset with the ability to manage conflicting interests. • Attention to detail and commitment to compliance. |
| Company Info | A global leader in insulin delivery solutions. One of the largest manufacturers of insulin syringes and pen needles, with a strong market presence in over 100 countries. The company focuses on Class II and Class III products, including insulin delivery devices and related diabetes management solutions. |
| English Level | Daily Conversation Level (TOEIC 475-730) |
| Japanese Level | Native Level |
| Salary | Depends on experience |
Additional listings by this company
You will now be redirected to an external site.
Please confirm each site’s terms of agreement (privacy policy) in regards to the management of personal information.
