Key Responsibilities:
Dossier Preparation Compile and Organize technical data into common technical document (CTD/ACTD) formats.
Regulatory submission draft, review, and file application like ANDA, and MAA to health agencies
Agency Linison: Act as the primary point of contact to negotiate and resolve queries from the FDA Regulatory Authority.
Compliance Monitoring Ensure Manufacturing Practices follow Valuable manufacturing Practices (GMP)
Lifecycle Management Oversee Mandatory post-market activities including annual renewals, Variations, and label changes.
Pay: ₹18,000.00 - ₹22,000.00 per month
Work Location: In person
📌 Ra Executive Ahmedabad
🏢 Sunrise Remedies, Santej
📍 Ahmedabad
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