Mukul Mehta

Assistant Manager @Avantor

Gurugram, IN

Ensuring business continuity through regulatory filings, obtaining regulatory approvals and continuously ensuring regulatory compliance.• Coordinates with Source Company and prepares document packages for regulatory submissions from all areas (Medical Devices & In vitro diagnostics, Drugs & Biological) of different franchisee of company.Keeps abreast of regulatory procedures and changes & regular direct interaction with regulatory agencies (DCGI, Drug Controllers Office, State FDA, ADC Airport & NIB, Noida) on defined matters.• Interacting with Marketing & Sales, R&D, Supply Chain & Finance department with respect to product, amendments in product specifications or manufacturing, packaging, manufacturing location, etc & provide regulatory support as and when required.• Actively making available all required documents/certificates for filing of tenders against the tender request from across all over the Indian market & other countries.• Maintaining the registration database & ensuring the regulatory compliance.Provide post market support to country management team eg. Approving & ensuring local country MRP labeling prior to custom clearance and before placing the product into the Indian market.• Timely reporting of adverse events/reports/product recalls notification letter to regulatory agency.• Review and approve Advertising and Promotional materials for all products to ensure regulatory compliance.• Monitor regulatory and compliance development within country and provide management with assessment of impact of changing or new upcoming regulations on businesses.

Panjab University

Master of Pharmacy (M.Pharm.), Pharmacy