Delhi, India
Regulatory Affairs professional with 11 years of experience, having thorough knowledge and skill sets regarding regulations of Drugs, Medical Devices and Diagnostics. Having blend of experiences of Pharma Quality Assurance and Regulatory Operations. Strong knowledge and experience of regulatory affairs for India, European, African and ASEAN countries and ROW. Having actively involved in harmonization of systems & procedures, Corporate Audit, cGMP compliance, Training, Support for Regulatory audits, Vendor qualification etc.
• Preparation & review of dossiers for registration of manufacturing premises and product (Drugs, Medical Devices & Diagnostics) for submission to O/o DCGI. • Preparations and submission of import license applications (Form-10) and endorsements for medical devices and diagnostics. • Registration of Class II and Class III medical devices (bone cements, orthopaedic implants, tracheostomy tubes, foley catheters, balloon catheters, blood components sets, knee replacements, wound dressing materials, stents etc.) • Successfully submitted dossiers on behalf of global medical devices companies. • Familiar to the requirement of ISO 13485 and CE certification of medical devices. • Preparation of Form 40, Form 44, POA, Form 8, Form-9, Form 12, TR-6 challan, Schedule D I and D II for various applications. • Preparation of query replies, post approval amendments/change notification of various applications of Drugs, Medical Devices & Diagnostics. • Coordinating with manufacturers & their Indian agent for collecting data to ensure successful submission & product approval within agreed timelines. • Follow up and Liaison with CDSCO officials related to submitted applications. • Coordinating submission of dossiers to NIB Noida, NABL certified laboratories for NOC.