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Regulatory Affairs Officer
7 days ago
We are looking for
**REGULATORY AFFAIRS OFFICER**
- BPharma / MPharma / BSc / MSc
- 1 - 2 years experience in Regulatory Affairs or relevant (_Freshers please do not apply_)
- English Speaking is a Must
- Work Timings: Mon to Sat, 10am to 6pm (2nd & 4th sat off)
- Salary 18 to 22000 PM, depending on suitability
**Should be able to handle**:
1. Preparation, Compilation of the CTD/ACTD dossiers for the ROW market.
2. Ensuring that quality standards are met and submissions meet within stipulated timelines.
3. Prepare accurate and timely responses to queries received from regulatory agencies.
4. Ensure that all product artwork is updated and submitted in correct format
5. Communicate and follow up with the agent for progress of registration submission.
6. Maintain record for the Dossier and sample submission.
7. Coordinate with other departments for for relevant documents required for dossier.
8. To review all the documents for accuracy as per ICH or Country specific requirement.
9. Responsible for Compilation & Review of Quality documents like RM/FP, STP, Stability Protocols & Report, Process Validation protocols & reports, Analytical method validations.
10. Arranging samples, working standard, artwork as per country requirement and submitting them to the Regulatory authority within a specified time frame.
11. Maintaining & updating country wise registration status and arranging for renewal.
12. Should have experience in Pharma Formulation Company
Please send updated CV + Current CC and Notice Period
Pooja Nair
Schedule:
- Day shift
Work Location: In person
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