Manager Regulatory Affairs

Provide regulatory pathway for FSSAI, Ayurvedic & Drug Products (New Product Introduction)
• Ensure compliance with all applicable National Regulations, Guidelines, Codes and with policies related to FSSAI, Ayurvedic & Drug products.
• Review DTM (Draft Text Matter) for FSSAI products
• Review composition (RDA limits), health claims on product label for FSSAI and AYUSH range of products.
• Liaison with regulatory authorities for various matters related to FSSAI products
• Track and review new regulations including FSSAI and AYUSH Guidelines/Regulations and communicate to CFT (Cross-functional Teams), the impact on new products and existing product portfolio
• Review and approval of promotional inputs for Nutra and Ayurvedic products.
• Maintenance of FSSAI licences including submission of annual returns to the Regulatory authority
• Provide technical inputs on review of CMC data for Central (CDSCO) and State dossiers related to new products under development
• Liaison with other departments such as l&D, Quality, Supply chain, Project Management, etc to deliver high quality dossiers, in accordance with business priorities
• SUGAM filing for CDSCO (Central Drugs Standard Control Organization) New drug products starting from initial application till approval
• Address queries from CDSCO & FSSAI on submitted applications.
• SEC recommendation -tracking, analysis and presentation to respective affiliates
• Provide Regulatory Support for on-time FSSAI, Ayurvedic & Drug Product new product launches