🚀 Hiring | Deputy Manager – Regulatory Affairs (Core RA | Pre-Approval | US/EU Complex Injectables)
📍 Ahmedabad, Gujarat
At Amneal Pharmaceuticals, we are hiring for a core Regulatory Affairs (Pre-Approval) role focused on new submissions for US FDA ANDA and EU markets.
⚠️ Note: This is NOT a plant/operations RA role. Candidates with only manufacturing/plant exposure may not be a fit.
🔬 Role Focus (Must-Have Experience):
• End-to-end pre-approval activities – Regulatory strategy → Filing → Deficiency responses
• Strong experience in US FDA ANDA submissions (mandatory)
• Hands-on work with Complex Injectables – Peptides, Microspheres, Liposomes, Nano-suspensions
• Drafting Pre-ANDA / Pre-IND / Scientific Advice meeting packages
• Preparing controlled correspondences for complex regulatory queries
• Review of API/FP characterization & DMFs
🎯 Ideal Profile:
• 8–10 years in Regulatory Affairs (Injectables – mandatory) | 12+ years overall
• Proven experience in core RA (pre-approval / new applications)
• Exposure to US & EU regulatory pathways
• M.Pharm / PhD (Regulatory Affairs / Pharmaceutics preferred)
• Strong ownership, decision-making ability, and cross-functional collaboration
📩 Only candidates with relevant US/EU Complex Injectable ANDA experience are encouraged to apply
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