RA Executive (For API Pharma at Vapi)

Mangalam Drugs & Organics; Vapi; On-site; INR 600,000 - 900,000; Full time

Job summary

Mangalam Drugs & Organics in India seeks a regulatory affairs specialist to prepare and issue letters of access for DMFs, submit DMFs and QOS for regulatory submissions, and address customer inquiries related to product DMFs.

You will prepare regulatory documents and dossiers in eCTD/NeeS format for global markets including WHO Geneva, Europe, China, ANVISA, and other ROW markets, and collaborate with QA, Analytical Development, and R&D to ensure compliance and market-specific requirements.

Qualifications

• DMF preparation and submission experience.
• Experience with regulatory documents and eCTD/NeeS formats.
• Ability to respond to customer inquiries on DMFs.

Responsibilities

• Prepare and issue Letter of Access for DMFs to customers, ensuring regulatory compliance.
• 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.

Skills

DMF preparation

Regulatory submissions

Cross-functional collaboration

Regulatory writing

Tools

eCTD/NeeS format

DMF submissions

Job description

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.