Regulatory Affairs Executive for Active Pharmaceutical Ingredients
Vapi, Gujarat, India · Full Time
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- 1
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- 4 மணி நேரம் முன்
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Job description
About Mangalam Drugs & Organics Limited
Since 1977, Mangalam Drugs & Organics Limited has been manufacturing Active Pharmaceutical Ingredients (APIs) and Intermediates at its Vapi, Gujarat facilities. The company operates multiple manufacturing sites and boasts an in-house Research & Development lab recognized by the Department of Scientific & Industrial Research (DSIR), Government of India. Mangalam holds a strong reputation across Asia as a leading producer of frontline Anti-Malaria APIs, complemented by a diverse portfolio of products optimized for operational synergies and economies of scale.
Key Responsibilities
- Draft and issue Letters of Access for Drug Master Files (DMFs) ensuring adherence to applicable regulatory standards.
- Prepare and submit DMFs along with Quality Overall Summary documents for regulatory approvals.
- Respond promptly and accurately to customer queries related to product-specific DMFs.
- Compile and submit regulatory dossiers and documents formatted in eCTD and NeeS for global markets, including WHO Geneva, Europe, China, ANVISA (Brazil), and other regions of the world.
- Work collaboratively with cross-functional departments such as Quality Assurance, Analytical Development, and Research & Development to maintain regulatory compliance and align product development with market-specific requirements.
Industry
Pharmaceuticals