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 (SOPs)
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 (SOPs).
Key responsibilities include ensuring product and GMP maintenance, managing product changes, preparing CTA submission documentation, and responding to regulatory authority queries.
The role involves relationship management with stakeholders, attending association meetings for updated regulatory information, and completing required trainings for 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 (SOPs).
Skills & Requirements
Must-have
product life-cycle management
clinical trial application
local regulations compliance
Pfizer Policy and SOPs
Nice-to-have
good communication skill
problem solving
analytical thinking
project management
teamwork
Key Requirements
Bachelor degree or above in pharmacy or science-related background