RAVINDRA TRIVEDI

Markets: Europe, South Africa, Philippines, Vietnam, Thailand & Myanmar

• Prepare, review, and submit regulatory documents to health authorities in assigned markets
• Ensure all products comply with local and international regulations and standards
• Manage the end-to-end process of product registration, including dossier preparation, submission, and follow-up
• Manage post-approval activities including variations and renewals
• Ensure product labelling meets regulatory requirements and is updated in accordance with regulatory changes
• Monitor and interpret regulatory changes and trends in the assigned markets to ensure proactive compliance
• Work closely with R&D, Quality Assurance, Marketing, and other departments to ensure regulatory requirements are met
• Maintain accurate and up-to-date regulatory documentation and databases
• Successfully delivered a range of projects on time and within scope.

Market: Zambia, Zimbabwe, Nigeria, Botswana, Tanzania, Sudan

• Prepared and submitted regulatory applications for product approval
• Managed documentation and ensured timely submission of dossiers to regulatory authorities
• Addressed and resolved regulatory queries from health authorities effectively
• Coordinated with internal teams to gather information and provide accurate responses
• Reviewed and approved product labelling and packaging to meet regulatory standards
• Acted as a key point of contact between the company and Gujarat FDCA for various approvals like COPP, FSC, Product permission and WHO GMP
• Monitored changes in regulatory policies and guidelines to ensure ongoing compliance
• Coordinated regulatory activities to support the successful launch of new products.

Markets: Uganda, Malawi, Tanzania, Cambodia, UAE

• Conduct regulatory research and analysis to identify and understand applicable regulations for pharmaceutical, Ayurvedic, and Food products in the target market.
• Preparation and submission of dossiers
• Manage the regulatory review and approval process, liaising with regulatory authorities and providing necessary information and clarifications
• Ensure compliance with labelling requirements, including ingredient declarations, nutritional information, and claims
• Maintain accurate and up-to-date regulatory records and documentation
• Collaborate with cross-functional teams (e.g., R&D, Quality, Marketing) to ensure regulatory compliance throughout the product lifecycle
• Provide regulatory support during audits conducted by Malawi & Tanzania FDA, including preparing documentation, answering questions, and ensuring compliance with audit requirements
• Key contact point for Liasoning activities with Gujarat FDCA for COPP, Product Permission, FSC & WHO GMP approvals.