Position Title: Regulatory Specialist
Location: Japan
Employment Type: Full-time
Job Summary
This role involves supporting regulatory submissions for veterinary medical devices and in-vitro diagnostic products in coordination with global headquarters and the Japan office. The position is responsible for preparing and submitting applications for marketing approval to relevant authorities such as the Ministry of Agriculture, Forestry and Fisheries. The role also includes addressing regulatory feedback, managing post-approval maintenance, and ensuring compliance with quality regulations such as the PMD Act.
Key Responsibilities
Lead the end-to-end process of regulatory applications, including study planning, data collection, report preparation, submission, and follow-up.
Liaise with manufacturing teams (including international headquarters) to obtain necessary documentation and data for regulatory submissions (occasional travel may be required).
Proactively identify opportunities to improve the application process and ensure timely approvals.
Build and maintain productive relationships with regulatory agencies through meetings, negotiations, and active participation in industry-related discussions.
Ensure adherence to applicable laws and regulations, including reviewing labeling, manuals, advertisements, and promotional materials for compliance.
Oversee quality management systems (GQP/GVP), including documentation, testing, and shipment release procedures.
Handle other related responsibilities as assigned.
Required Experience & Qualifications
Prior experience with regulatory submissions for medical or veterinary products.
Pharmacist license is a plus but not mandatory.
Required Skills
Strong understanding of relevant regulations such as the PMD Act and the Poisonous and Deleterious Substances Control Act; willingness to deepen regulatory expertise.
Ability to independently manage and coordinate complex projects.
Proficient written communication skills in both Japanese and English.
Clear and confident presentation and explanation abilities.
Strong organizational skills with the ability to manage multiple deadlines.
Excellent interpersonal skills, with the ability to communicate effectively across internal and external stakeholders, including international teams.
Practical, compliance-focused mindset balanced with business understanding.
Proficiency in English.
Basic proficiency in Microsoft Word and Excel.