Job Description

We are hiring a

Senior Regulatory Affairs Executive

with around

5 years of experience

in regulatory submissions for international markets, especially

USFDA and EDQM

.

This role involves end-to-end regulatory dossier preparation and submission, technical data coordination, and maintaining compliance with global regulatory standards in an

API manufacturing

environment.

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

:

DNK SQUARE SAKORE NAGAR VIMAN NAGAR

Contact for applying - 8956760759

Mail- recruitment@dnplfactory.com

Job Type: Full-time

Pay: ?25,000.00 - ?60,000.00 per month

Benefits:

Provident Fund
Work Location: In person