Regulatory Officer at Concept… · Mumbai…

Job Title: Regulatory Affairs Manager

Company: Concept Pharmaceuticals Ltd
Location: Andheri, Mumbai

Job Summary

Concept Pharma is looking for a qualified and experienced Regulatory Affairs professional 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 hrd@conceptpharma.com with the subject line: Application for Regulatory Affairs Executive

or whatsapp your CV on 9870949809