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Executive - Regulatory Affairs (OSD)

Executive - Regulatory Affairs (OSD)

Lee Pharma

2 - 4 years

3 - 5 Lacs

Visakhapatnam

Posted:15 hours ago| Platform:

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Skills Required

Drug Regulatory Affairs Regulatory Guidelines Dossier Preparation Dmf

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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

www.leepharma.com

Pharmaceuticals

Philly

200 Employees

10 Jobs

Key People

John Lee

CEO
Sara Patel

Chief Operating Officer
Emily Tran

Head of R&D

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