- 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 Positive 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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