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 lD, 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