RA Executive (For API Pharma at Vapi)

Key Responsibilities:

• 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.