募集要項

募集背景: Responsible for the overall management of regulatory affairs activities including pharmacovigilance work at RA department at PDRA division Animal Health in Japan. The position requires a combination of scientific knowledge, understanding of regulatory requirements, strategic thinking, and team leadership to ensure timely development of new products and regulatory affairs activities.

仕事内容: Reporting lines:
・Directly to the PDRA director
・Manages a team of 5-7 colleagues of RA department.

The role involves leading the Regulatory Affairs (RA) team and supporting the PDRA Director in maximizing departmental performance. Key responsibilities include aligning with PD on gap analysis and product profiles, integrating local regulatory needs into global development plans, and liaising with Sales to assess market potential for new or improved veterinary products. The RA lead will ensure timely development and registration of biological and pharmaceutical veterinary products in Japan, in compliance with local laws and global guidelines. Oversight of CROs, ensuring contract and quality compliance, is also required. The role ensures adherence to national and international pharmacovigilance requirements and internal processes. Additionally, the RA lead will advise on strategic regulatory trends and support team development through coaching, motivation, performance evaluation, and setting individual objectives in alignment with both global and local development goals.

応募資格

必須: ・Language – Japanese (fluent), English (professional level – verbal and writing)
・Highly developed skills in negotiating, influencing, leadership and staff motivation.
・Excellent communication and organizational skills.
・Ability to work well with other departments in a multicultural team setting and matrix organization
・Familiarity with animal diseases and animal husbandry techniques and ability to understand our product users including farmers and veterinarians.
・Knowledge of Microsoft Office

会社概要