Career Opportunity: Manager – Regulatory Affairs Job at Abbott | Mumbai, India- Apply Now 

Career Opportunity: Manager – Regulatory Affairs Job at Abbott | Mumbai, India- Apply Now 

Abbott, a global leader in healthcare and pharmaceutical innovation, is hiring a Manager for regulatory Affairs in Mumbai, Maharashtra, India. This role focuses on FSSAI filings, drug filings, and Ayurvedic product compliance, ensuring adherence to national regulations and guidelines. If you have 8-10 years of regulatory experience and expertise in FSSAI and CDSCO filings, this could be the perfect opportunity for you. Apply now and be part of Abbott’s mission to improve health worldwide!

Job Title: Manager Regulatory Affairs

Location: Mumbai, Maharashtra, India

Job Description

Minimum Education: M. Pharm/B. Pharm

Minimum Experience Required: 8-10 years in FSSAI filings (mandatory) / Drug filings

Responsibilities:

• 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

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Keywords: Regulatory Affairs, FSSAI Filing, Drug Filing, Ayurvedic Products, Compliance, Regulations, Guidelines