Dra Officer

3 months ago

Delhi, India Akums Drugs & Pharmaceuticals Ltd. Full time

1. Follow up from plant R&D Team for AMD, AMV, Tech Transfer, Stability Charging Date, AMV timeline
2. Follow up with Purchase Dept for API Documents and review of API Documents of vendor.

3. Dossier Compilation & Review of both Finished Product and API

4. Review of artwork for DCGI Prepare all modules (Module 1,2,3,4 & 5) and submit to CDSCO.

5. Prepare Dossier for IPC Submission and reply of Subsequent Queries Independently.

7. Reply to Business Development Department on Techical Queries received from Clients
8. Communication with CRO regarding BE, CT & Toxicity Protocol and related Documents (Site addition, Site Initation, SIP, IMP etc)

10. Preparation of all technical document of dossier like package insert, rationale, drug-drug interaction.

Pay: ₹25,000.00 - ₹350,000.00 per month

**Benefits**:

- Health insurance

Schedule:

- Day shift

Ability to commute/relocate:

- Delhi, Delhi: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- Drug regulatory affairs: 1 year (required)

**Speak with the employer**
+91 8800461116

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