Animal Health, Regulatory Affairs
Core
Manage regulatory affairs and pharmacovigilance activities to ensure timely product registration of biological and pharmaceutical veterinary products in Japan.
Role type
Associate Director, Regulatory Affairs
Builds
Biological and pharmaceutical veterinary products for the Japanese market
Domain
Animal Health / Veterinary Vaccines / Pharmaceuticals
Required skills
Regulatory Affairs Management, Pharmacovigilance, Product Registrations, Strategic Thinking, Team Leadership, Budget Planning, CRO Management, Gap Analysis, Policy Implementation
Preferred skills
Knowledge of Japanese Regulatory System, Experience in Veterinary Vaccines, Matrix Environment Navigation
Technologies
Microsoft Office
Responsibilities
Lead the RA team to ensure timely development of veterinary products in compliance with local laws; Optimize development plans by leveraging global data; Oversee collaborations and quality of Contract Research Organizations (CROs); Ensure compliance of organizational structures and pharmacovigilance requirements; Mentor and coach team members to maximize capability; Liaise with Product Development and Sales to align market requirements with regulatory submissions.
Seniority
Senior, hands-on IC with leadership responsibilities