Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
Post : Manager Regulatory Affairs
Job Description
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
Additional Information
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th March 2025
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