Job Description
We are hiring a Senior Regulatory Affairs Executive with around 3 - 6 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:
Work Location: In person
