Lupin is hiring an Executive – Regulatory Affairs in Pune Biotech, Maharashtra. This opportunity is ideal for professionals with 3–5 years of regulatory affairs experience in the pharmaceutical or biotechnology domain. If you have expertise in regulatory submissions, GMP documentation, and post-approval changes (PAC), this role offers strong career growth in a globally recognized pharma company.

This Regulatory Affairs job in Pune focuses on managing submissions across India, emerging markets, and regulated markets, making it highly relevant for candidates seeking global exposure in regulatory operations.

🔍 Job Overview

• Role: Executive – Regulatory Affairs
• Company: Lupin
• Location: Pune Biotech, Maharashtra, India
• Experience: 3–5 Years
• Qualification: M.Pharm / MSc Biotechnology / Biopharmaceutics / Pharmaceutical Technology
• Job Type: Full-Time

📌 Key Responsibilities

• Draft and compile regulatory submission dossiers for domestic, emerging, and regulated markets
• Handle queries from global health authorities efficiently
• Review GMP documents in line with regulatory compliance standards
• Prepare and manage Post Approval Change (PAC) applications
• Coordinate with international partners for marketing authorization applications (MAA)
• Manage online regulatory submission portals across different geographies
• Support regulatory strategy for biosimilar products (preferred skill)
• Ensure strong documentation, communication, and compliance practices

🎓 Qualifications & Eligibility

• Master’s Degree in Pharmacy / Biotechnology / Biopharmaceutics / Pharmaceutical Technology
• 3–5 years of experience in Regulatory Affairs
• Strong understanding of:
  • Global regulatory submission processes
  • GMP documentation
  • Regulatory compliance requirements
• Excellent written and verbal communication skills

💼 Why Join Lupin?

• Work with a top-tier global pharmaceutical company
• Exposure to regulated and emerging markets
• Hands-on experience with global regulatory submissions
• Career growth in biosimilars and advanced pharma domains
• Collaborative and compliance-driven work environment

🚀 How to Apply

Application Link