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Amneal Pharmaceuticals
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Senior Executive, Regulatory Affairs (API-DMF Filing)

Senior Executive, Regulatory Affairs (API-DMF Filing)

Amneal Pharmaceuticals

6 - 9 years

|

7 - 8 Lacs

Posted:-1 days ago| Platform:

Apply

Skills Required

executive regulatory affairs compliance anda qaqc monitoring ich auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Prepare and compile DMF/ANDA Drug Substance modules (especially Module 2 & 3) in compliance with regulatory requirements.
Review DMF submissions and respond to regulatory deficiencies and queries in a timely and accurate manner.
Coordinate with internal teams (R&D, QA/QC, Manufacturing) and external stakeholders to gather and validate required documentation.
Ensure alignment with FDA and ICH guidelines throughout the submission lifecycle.
Monitor regulatory updates and proactively implement changes in submission strategy.
Maintain regulatory documentation and track submission timelines and approvals.
Participate in audits and inspections, providing regulatory support and documentation as needed.

Required Skills:

DMF/ANDA Drug Substance Module Preparation | Expert
DMF Review & Deficiency Response | Advanced
FDA & ICH Guidelines | Expert
Regulatory Documentation & Submission Systems | Advanced

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