Associate Director, Regulatory Affairs – Animal Health

About the role

The Associate Director of Regulatory Affairs leads the RA team within the Animal Health division in Japan, ensuring timely product registrations and compliance with local pharmaceutical regulations.

Key responsibilities

• Lead the RA team to ensure timely development of veterinary products in Japan, complying with local regulations.
• Develop and execute project plans for product registrations, leveraging global data and coordinating with CROs.
• Collaborate with Product Development and Sales to align product profiles, market potential, and regulatory submissions.
• Ensure compliance with pharmacovigilance requirements and internal processes.

Required profile

• Veterinarian or PhD in Biological/Animal Sciences (preferred).
• Minimum 7 years experience in a regulated industry, preferably veterinary vaccines or pharmaceuticals.
• Experience leading teams, coaching, and working in matrix environments.
• Knowledge of the Japanese regulatory system (preferred).

Required skills

• Fluent Japanese and professional English (verbal and written).
• Negotiation, influencing, leadership, and staff motivation.
• Excellent communication and organizational abilities.
• Familiarity with animal diseases, husbandry techniques, and product users.
• Proficiency with Microsoft Office.