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Senior Regulatory Affairs Executive

Senior Regulatory Affairs Executive

Deccan Nutraceuticals

2 - 5 years

4 - 8 Lacs

Pune

Posted:3 days ago| Platform:

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Skills Required

USFDA Regulatory Audits EDQM Dmf API Regulatory Documentation Interdepartmental Coordination CEP

Work Mode

Work from Office

Job Type

Full Time

Job Description

Senior Regulatory Affairs Executive

API manufacturing

Key Responsibilities

Prepare, compile, and submit regulatory dossiers (DMFs, CEPs, ASMFs) to international authorities, focusing on EDQM and USFDA.
Coordinate cross-functionally with R&D, QA, QC, and Production teams for document and data collection.
Maintain submission timelines and follow-up systems for timely responses and approvals.
Provide regulatory intelligence, evaluate changing guidelines, and ensure compliance for ongoing projects.
Handle deficiency responses and audits with strong documentation and archiving practices.
Act as a regulatory liaison with internal and external stakeholders.

Job Location

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