薬事スペシャリスト/RA Specialist
Core
Manage DMF registrations and changes for pharmaceutical and regenerative medicine raw materials, handle regulatory submissions for medical devices/diagnostics/veterinary products, and oversee Good Veterinary Practice (GVP) safety reporting.
Role type
Regulatory Affairs Specialist (RA) / Quality Assurance
Builds
Regulatory compliance and safety reporting for life sciences products
Domain
Life Sciences / Pharmaceuticals / Medical Devices
Deliverable
client delivery
Required skills
DMF registration and change management, regulatory document creation and interpretation, safety incident and adverse event reporting, regulatory information monitoring, industry association liaison
Preferred skills
DMF registration experience, regulatory authority interaction experience, global meeting participation, pharmacist qualification
Technologies
Regulatory databases, GVP procedures
Responsibilities
Coordinate with global teams for new DMF registrations and modifications; manage label and package insert changes for medical devices and veterinary products; collect, evaluate, and report safety incidents and side effects to authorities; monitor and disseminate regulatory updates from industry associations
Seniority
Staff level, individual contributor