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 stakeholders, attending association meetings for updated regulatory information, and completing required trainings to ensure compliance with Pfizer Policy and SOPs.
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.