Executive - Regulatory Affairs (OSD)

2 - 4 years

3 - 5 Lacs

Posted:1 month ago| Platform: Naukri logo

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Work from Office

Job Type

Full Time

Job Description

1. Preparation and review of Drug Master Files, Dossiers as per regulatory guidelines. 2. Ensuring compliance with regulations set by the authorities. 3. Keeping up to date with changes in regulatory legislation and guidelines. 4. Analyzing complicated information & data provided by other departments, including trial data. 5. Ensuring that quality standards are met and submissions meet strict timelines. 6. Coordination with QA, QC & R&D to get documentation required for preparation of Drug Master Files & Technical dossiers. 7. Responsible for DMF/Dossier updations, revisions. 8. Responding to Customers and Regulatory Authorities on technical queries in time. 9. Maintaining customer correspondences.

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Lee Pharma logo
Lee Pharma

Pharmaceuticals

Philly

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