MONIKA BANO

Regulatory Affairs – Food and Supplement Products (International and Domestic Markets)

• Managed end-to-end product registration processes in compliance with domestic and international food regulations.
• Prepared and submitted registration dossiers, including formulations, CoAs, safety data, and product specifications.
• Oversaw label design, content review, and claims verification to ensure compliance with FSSAI, USFDA, ITALY, FRANCE, SPAIN, GERMANY, BELGIUM, IRELAND, PORTUGAL, and other market-specific guidelines.
• Coordinated multilingual label translations, and verified accuracy for local market requirements.
• Monitored regulatory updates, and ensured timely implementation of changes in product labels and documentation.
• Collaborated with R&D, QA, marketing, and export teams to align product compliance with market needs.
• Resolved regulatory queries and objections from authorities in a timely and compliant manner.

• Assisting in achieving overall conformance with FSSAI regulations.
• Providing labeling guidelines as per FSSAI.
• Registration or filing of FSSAI licenses.
• Checking for regular follow-ups and timely responses to the queries raised by FSSAI.
• Liaising with FSSAI department officials for better and more effective communication.
• US FDA Food Facility Registration.

• Assisting in achieving overall conformance with FSSAI regulations.
• FSVP documentation for the US FDA.
• Responsible for export/import compliance and US FDA food facility registration.
• Keeping up to date with country-wise regulatory requirements (India, US, Canada, Australia, New Zealand, Middle East, China).
• Providing labeling guidelines as per FSSAI.
• Responsible for label compliance for domestic and export food products.
• Registration or filing of FSSAI licenses, and annual returns.
• Updating the product documentation (ingredients list, nutritional data, composition details, etc.).
• Responsible for the quality compliance of food products as per FSSC 22000.
• Delivered subject matter expertise for internal and external compliance, and quality control.
• Product barcode generation and maintaining the data.

• Assisting in achieving overall conformance with FSSAI regulations.
• Providing labeling guidelines as per FSSAI.
• Registration or filing of FSSAI licenses, and annual returns.
• Updating the product documentation (ingredients list, nutritional data, composition details, etc.).

Company Overview: In joint venture with GlaxoSmithKline (GSK) HealthCare Limited.