Executives In Regulatory Affairs Job in Micro Labs Ltd

Executives In Regulatory Affairs

Micro Labs Ltd 4+ weeks ago

• Bengaluru, Bangalore Urban, Karnataka
• Not Disclosed
• Full-time
• Permanent

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Job Summary

- 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

Qualification :
B.Pharm, M.Pharm

Experience Required :

3 to 5 Years

Vacancy :

2 - 4 Hires

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