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Executive, Regulatory Affairs

5 - 8 years

4 - 6 Lacs

Posted:9 hours ago| Platform: Naukri logo

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Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Dossier Preparation in CTD/ACTD/Country Specific Formats

2. Re-registration and Renewal Application

3. Variation Application

4. Queries Handling

5. DMF Activity

6. Artwork Review (Carton/Foil/Label/Insert/Shipper)

7. Pack Insert Preparation as per Country Guideline

8. Documents and Sample Collection Activity from F&D, QA, QC and Store department for registration requirement.

9. Documents Review Knowledge: Pharmaceutical Development Report, Process Validation Protocol & Report, Excipients Specifications/MOA, Finished Product Specification/MOA, Packing Material Specification/MOA, COA, Stability Study Protocol & Report, MFR, BMR, BPR, Clinical/Non Clinical Literature Search Strategy, AMV, CDP, BE Study.

Experience Required: CDSCO

Dosage Form Experience Required:

Tablets, Capsules, Oral Powder (Sachet), External Preparation (Gel & Cream), Injections, Infusions, Suspension, Syrup, Oral Drops, Suppositories.

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