Regulatory Affairs Executive jobs
Job Description
- Responsible for compilation and review of dossier for a product for the regulated markets and customers
- Circulate checklist for dossier requirements
- Coordinate with R&D, QA, QC and production for documents
- Prepare Module 1 and Module 2 (Quality) and Module 3 as in eCTD/ NeeS as per EU / ANDA requirements or country specific requirements
- Hyperlink and upload the dossier in eCTD software
- Circulate query checklist and compile query response
- Compile documents for post approval variations
- Compilation of annual reports and renewal documents
Posts
