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 assigned products and GMPs are maintained in full compliance, communicating key changes to stakeholders, and preparing CTA submission documentation.
The role involves managing relationships with stakeholders, attending association meetings for updated regulatory information, 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 (SOPs).