Description and Requirements
This role will be more regulatory background with Data management. Junior RA person with data management and project management. they will support EMEA - regional support
Regulatory Affair background is must now
6 months experience, no more than 2 years in Medical Device/Pharma
All the comments on authorities are in the system and they need this technical support. The data is via email or the system itself. No need to understand the content of the data but knowledge of systems. There will be many kinds of information, they will receive the information - follow the process to the system - notification will say what to do in the system.
English is needed
NICE TO HAVE
Knowledge/experience in Medical Devices
Information Administrator (in the Regulatory field)
Drawing on existing data repository and decision matrix to complete regulatory assessment and initiate, complete and close simple regulatory actions within the clients management system.
Customer (country) support in data reporting and system updates.
- From varying data sources, identify and extract required regulatory requirements to complete Regulatory Impact Assessment
- Create, update and complete RA actions within required system
- Monitor and coordinate with EMEAC countries the execution RA actions leading to regulatory submission
- Maintain trackers and database
- Maintain data integrity in client's system
- Participate in process improvement
Provide input for the planning and development of a centralized regulatory database system to help identify and align both local and global regulatory organization.
· Proven data administration experience
· Strong database experience
· Strong team player
· Good level in English (spoken and written)
Good experience in MS Excel/ Pivot