Regulatory Affairs Executive (Pharma)

Concept Pharmaceuticals; Mumbai; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Concept Pharma in Mumbai is seeking an experienced Regulatory Affairs professional to manage regulatory submissions and ensure compliance for pharmaceutical products in domestic and international markets.

The role involves preparing and submitting regulatory dossiers (CTD / eCTD) for ANDA, NDA, DMF, MA, and coordinating with R&D, QA, QC, Manufacturing, and Marketing teams to meet regulatory requirements and respond to agency inquiries.

Qualifications

• 5-10+ years of Regulatory Affairs experience.

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

Job description

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 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