Executive

Job Description

• Preparation of Drug Master File (DMF) for all markets.
• Preparation of the technical package.
• Review of documents, including specifications, batch manufacturing records, etc. 
• Compilation of deficiency responses and review of related documents.
• Issuance of various types of declarations and Letters of Authorization (LOAs) as required for different markets.
• Compilation and submission of DMF amendments and annual reports.
• Uploading of submissions through eDossier Universal Content Environment (eDUCE) and other regulatory platforms to various agencies.

Work Experience

4-5 Years of API background, able to handle the task independently

Education

Competencies