Job Title: Regulatory Affairs Executive

Company: Concept Pharma
Location: Andheri, Mumbai
Experience: 2+ Years
Salary: ₹4–9 Lakhs per annum (Negotiable)

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 +91-XXXXXXXXXX

Pay: From ₹35,000.00 per month

Benefits:

- Provident Fund

Work Location: In person

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