Job Title: Regulatory Affairs Executive (Male Only)

Company: Concept Pharma
Location: Andheri, Mumbai
Experience: 5-10+ Years

Job Summary

Concept Pharma is looking for a qualified and experienced Regulatory Affairs skilled to manage regulatory submissions and ensure compliance with applicable regulations for pharmaceutical products in domestic and international markets.

Key Responsibilities

- Preparation, review, and submission of regulatory dossiers (CTD / eCTD) for ANDA, NDA, DMF, MA, and product registrations
- Handling submissions to regulatory authorities such as CDSCO, USFDA, EMA, MHRA, and other global agencies
- Coordination with R&D;, QA, QC, Manufacturing, and Marketing teams for regulatory requirements
- Compilation and submission of post-approval variations,



renewals, amendments, and supplements
- Ensuring compliance with current regulatory guidelines and updates
- Responding to regulatory queries, deficiency letters, and agency communications
- Maintaining regulatory documentation and tracking submission timelines
- Supporting audits and inspections related to regulatory compliance

How to Apply

Interested candidates can share their updated resume at [email protected] with the subject line: Application for Regulatory Affairs Executive

or whatsapp your CV on (phone hidden)

📌 Regulatory Affairs Executive (Pharma) (Mumbai)
🏢 Concept Pharmaceuticals
📍 Mumbai