Neha Mehta

Regulatory affairs , Quality of management

• Present the Stage Gates to all stakeholders for discussion on Ongoing and upcoming Projects to monitor the progress of the Projects • Monitoring resource needs, issues, developing action plans to ensure program commitments • Managing Project Portfolio Management processes globally. Manage complex outsourcing process with CMO (Contract Manufacturing Outsourcing • Maintain project work on PMP-MSP/ SAP and regulatory database up to date.

Department: Regulatory Affairs & Analytical Compliance for CMC review and Query • Prepared & managed regulatory submissions & queries for various dosage forms (Solid, Orals, Liquids, Parenteral) and post approval lifecycle management (variations/Supplements/Amendments, Renewals, CTD updates) • Compliance activities (CMC Change Control, review of dossiers for Registration, re-registration submissions). compile Dossier in EMEA, MHRA, USFDA , TGA, Health Canada and Emerging Markets.

• Developed rigorous testing of the analytical methods to ensure that they are precise, accurate, reproducible, and specific to the product requirements • Managed routine maintenance, calibration and troubleshooting for the analytical equipment on a regular basis for higher productivity and efficiency • ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA), USFDA and Health Care Canada

Quality Assurance Officer ITL Labs Private Limited (India) • Performed the testing of drug product, identified & improved the number of Corrective and Preventive Actions (CAPAs) • Handled laboratory events/exceptions (OOS, OOT, Worked in Quality Assurance in accordance to ISO IEC 17025) and performed internal audits, document review to ensure the compliance & regulatory guidelines (ISO 9001 and ISO IEC 170025) • Handled the Audits of ISO IEC 17025 and ISO 9001

Certificate

Project Management and international marketing

Chemistry

Chemistry