We are looking for RA executives with 2- 5 years experience in EU Submissions or at least with Drug product submissions to authorities in eCTD format.
- Preparation of Dossiers in eCTD format.
- Response to the Queries received from Regulatory authority / Stake holders.
- Review and preparation of Dossier review reports of Dossiers received.
- Preparation of Module 1 Documents
- Preparation of documentation for filing variations to Regulatory authorities
- MA Transfer of the Product approved with Regulatory authorities
- Effective communication and writing emails.
- Communication with all stake holders to drive the project.
Job Type: Full-time
Pay: ₹350,000.00 - ₹1,000,000.00 per year
Benefits:
Cell phone reimbursement
Health insurance
Internet reimbursement
Leave encashment
Paid sick time
Work Location: In person
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