Senior Specialist, Regulatory Affairs (Animal Health)
Core
Develop and execute regulatory strategies to ensure timely registration, lifecycle maintenance, and compliance of Animal Health products in Malaysia, Singapore, and Brunei.
Role type
Senior Regulatory Affairs Manager (Animal Health)
Builds
Product registrations and lifecycle management for Animal Health products
Domain
Animal Health / Veterinary Pharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy development, risk assessment, project management, regulatory submissions management, compliance monitoring, cross-functional collaboration
Preferred skills
Registered Pharmacist or Veterinarian qualification, Advanced degree in Regulatory Affairs, Animal Health or Veterinary products experience
Technologies
Microsoft Office, regulatory information systems
Responsibilities
Manage regulatory submissions for new registrations, renewals, variations, and labeling changes; Act as primary contact with regulatory authorities and industry associations; Monitor regulatory changes and assess business impact; Collaborate with Commercial, Quality, Pharmacovigilance, Supply Chain, and Technical teams
Seniority
Senior, hands-on IC