Job Title: Regulatory Affairs Executive
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
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 9870949809
Pay: From ₹45,000.00 per month
Benefits:
Work Location: In person
