The Regulatory Affairs Specialist is responsible for implementing clinical trial applications and product life-cycle management in compliance with local regulations and Company Standard Operating Procedures
Job Summary
The Regulatory Affairs Specialist is responsible for implementing clinical trial applications and product life-cycle management in compliance with local regulations and Company Standard Operating Procedures.
Key responsibilities include ensuring product and GMP maintenance, managing product changes, preparing CTA submission documentation, and responding to regulatory authority queries.
The role involves cooperating with relevant stakeholders, attending association meetings for regulatory updates, and completing required trainings to ensure compliance.
Matching Summary
The Regulatory Affairs Specialist is responsible for implementing clinical trial applications and product life-cycle management in compliance with local regulations and Company Standard Operating Procedures.
Skills & Requirements
Must-have
product life-cycle management
clinical trial application
regulatory compliance
local regulations
company SOPs
Nice-to-have
good communication skill
problem solving
analytical thinking
teamwork
updated regulatory information
Key Requirements
Bachelor degree or above, major in pharmacy or science