Regulatory Affairs Specialist is responsible for the implementation of clinical trial application and product life-cycle management in compliance with local regulations and Company Standard Operating Procedures (SOPs)
Job Summary
Regulatory Affairs Specialist is responsible for the implementation of clinical trial application and product life-cycle management in compliance with local regulations and Company Standard Operating Procedures (SOPs).
In partnership with above-country operational hubs, regulatory strategists, and local clinical operations or third party vendors, prepare agreed CTA submission documentation for initial application and amendments.
Cooperate with relevant stakeholders to share information and provide a good understanding on RA-related issues, and attend Association Meetings to get updated regulatory information.
Matching Summary
Regulatory Affairs Specialist is responsible for the implementation of clinical trial application and product life-cycle management in compliance with local regulations and Company Standard Operating Procedures (SOPs).
Skills & Requirements
Must-have
Clinical trial application preparation
Product life-cycle management
Compliance with local regulations
Good communication skill
Problem solving
Analytical thinking
Project management
Nice-to-have
Teamwork
Relationship management with stakeholders
Attend association meetings
Key Requirements
Bachelor degree or above in pharmacy or science-related background