Senior Executive, Regulatory Affairs

About the role

Regulatory Affairs team at Amneal ensures compliance and timely submissions of CMC dossiers for sterile dosage forms. The Senior Executive prepares, reviews and submits IND, NDA and ANDA filings to the US FDA, manages post‑approval supplements and coordinates with R&D and manufacturing to gather required documentation. Ahmedabad City, Gujarat, India – On-site work model.

What you’ll do

• Prepare, review and submit IND, NDA, ANDA dossiers to FDA
• Develop CMC regulatory strategies for submissions and lifecycle management
• Assess deficiency letters and coordinate response strategies
• Compile and submit post‑approval supplements such as CBE and PAS
• Maintain compliance with ICH, FDA and eCTD regulations
• Coordinate documentation across R&D, manufacturing and purchasing teams

What you’ll bring

• B.Pharm – Required
• M.Pharm – Preferred
• 5-8 years regulatory affairs experience

Skills