Mihira Dhuri

• Managing regulatory documentation process for new product registration in accordance with authority requirements.
• Responsible for obtaining successful registrations of Food, Pharmaceutical, and Personal Care - Healthcare Products in India.
• Ensuring receipt of Quality Certificate from suppliers (ISO, HACCP, GMP etc.) to manage product shipment clearance.
• Tracking all information and data; on-time communication with internal and external stakeholders for smooth workflow.
• Maintaining and monitoring clean, standardized, and validated product data in system and coordinating within organization to support business process.
• Managing expectations of diverse internal customers.
• Supporting with collating requirements to ensure item master registration of New Products in system.
• Responding to queries/document requests from customers and following up with suppliers with information to close loop.
• Resolving queries using one's technical knowledge.
• Assist in registration process and HS code clarification with authorities to ensure regulatory compliances.
• Managing renewals of company licenses/product licenses as required.
• Reviewing of Quality and Technical Agreements.
• Preparing and monitoring SOPs and policies for warehouse activity, conducting internal audits at warehouse locations.
• Training warehouse staff towards SOPs and policy compliance.

• Dossier collation for pharmaceutical and nutraceutical products, as per market-specific requirements.
• Targets for obtaining timely regulatory approvals.
• Providing extensive support to customers for regulatory filings, agency deficiencies, and technical requirements.
• Adopting regulatory guidelines for improving quality of regulatory submissions and deficiency responses.
• Filling of tenders for India and international market.
• Reviewing and preparation of artworks and coordinating with designer.

• Dossier collation for veterinary pharmaceutical and feed products, as per market-specific requirements.
• Worked on dossiers for new registration in different countries, e.g. Dominican Republic, Guatemala, Ecuador, UAE, Thailand, South Korea, etc.
• Communicating with distributors/consultants to get regulatory approvals.
• Coordinating with Plant QA/RA, Purchase team, Artwork team, etc., for collation of dossiers.
• Liaising with state FDA for approval of products and renewal of licenses.

Targets for obtaining timely regulatory approvals.

• Responsible for collation and submission of dossiers of Cardiovascular, Orthopedics, and Endo-Surgery range of products for Latin American countries.
• Resolving queries and liaising with Regulatory Authorities for approval of devices.
• Coordination with R&D, Plant QA/RA for collation of dossiers.
• Updating and maintaining documentation required for submission.
• Coordination with Internal Sales Team for registration of products in Latin American countries.
• Reviewing of Spanish-translated documents of products before submission of dossiers to respective registering authorities.
• Keeping track of changes in regulations in Latin American countries and accordingly planning registration and renewal of products.
• Maintaining PMS records and handling product complaints.
• Processing documents for legalization, required for global submissions.