- Prepare and Issue Letter of Access for Drug Master Files (DMFs) to customers, ensuring compliance with regulatory requirements.
- Prepare and Submit DMFs and Quality Overall Summaries for regulatory submissions.
- Address Customer Inquiries related to product DMF.
- Prepare and Submit Regulatory Documents and Dossiers in eCTD/NeeS format for global markets, including WHO Geneva, Europe, China, ANVISA (Brazil), and other ROW markets.
- Collaborate with Cross-functional Teams (Quality Assurance, Analytical Development, and R&D;) to ensure regulatory compliance and that product development meets the specific requirements of each market.
📌 RA Executive (For API Pharma at Vapi)
🏢 Mangalam Drugs & Organics
📍 Vapi
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