Regulatory Affairs Executive(API)

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- [email protected]

Job Type: Full-time

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

Benefits:

• Provident Fund

Work Location: In person