Animal Health, Regulatory Affairs
Core
Manage regulatory affairs and pharmacovigilance activities to ensure timely registration of veterinary biological and pharmaceutical products in Japan.
Role type
Associate Director, Regulatory Affairs (Team Lead)
Builds
Regulatory submission packages and product registrations for veterinary vaccines and pharmaceuticals
Domain
Animal Health / Veterinary Pharmaceuticals
Deliverable
product features
Required skills
Regulatory Affairs Management, Pharmacovigilance, Product Registrations, Strategic Thinking, Team Leadership, Budget Planning, CRO Management, Gap Analysis, Global-Local Harmonization
Preferred skills
Knowledge of Japanese Regulatory System, Experience in Veterinary Vaccines, Matrix Organization Navigation
Technologies
Microsoft Office
Responsibilities
Lead the RA team to ensure compliance with Japanese pharmaceutical laws and guidelines; Optimize development plans by leveraging global data; Oversee collaborations and quality of Contract Research Organizations (CROs); Coordinate with Product Development to align product profiles and submission strategies; Mentor and coach team members to maximize capability; Liaise with Sales BU to identify market requirements for new products.
