Sachinkumar Gupta

Background

About Sachinkumar Gupta

A Pharmacy graduate, with 13+ years of experience in Drug regulatory affairs (DRA) in CMC and Safety, for Innovative Medicines, Generics, Complex Generics, Drug Delivery Devices combination; new / initial filings and product life cycle management i.e. filing of Variations, Renewals and Annual Reports * Experienced in In-house Development / Own Registration, In-licensed as well as Out-Licensed / B2B projects; comprising various pharmaceutical dosage forms * Project Management in close liaison between global and local colleagues/ stake holders and provide input and implement - Regulatory Strategy and Regulatory Functional Plan (RFP), including identification of gaps or risks in global strategic plan across the portfolio and managing operational activities * Business Development process and Due Diligence / Dossier Audit of In- licensed projects; insight into contracts with license partners and regulatory management of in- licensed projects * Liaise directly with EMA, MHRA, BfArM and US FDA, on Regulatory strategy and Negotiation * Participation in relevant regulatory Boards leading to valuable input from these Boards, to achieve business objectives * Review and provide input on global dossier, summary documents, briefing books, IB and CDS, consistent with development data and commercial objectives. Assists with generating local PIs and ensuring that they are integrated with the CDS. Contributes to identifying potential label issues/gaps and develops regulatory label negotiation strategy with contingency planning * Review and provide regulatory on Aggregate reports, PSUR, PADER DSUR, ACO with respect to actions taken due to safety reasons, changes of the reference safety information, EU & US regional appendices, world-wide MA status, introduction / summary for innovative medicines * Skilled in authoring module 1, 2, module 3 and module 5 i.e. CMC and Safety documents * Maintenance of Pre and Post marketing notification including Sunset Clause in EU * Creation / maintenance of Product information text as per QRD Template (EU) and package insert including SPL compilation (NDA and ANDA)* Experienced in negotiation with health authority and end-to-end regulatory compliance with Launch management * Regulatory Commitments - Tracking and Meeting * Quality Management System (QMS), Change Control Management * Cross-functional working, Collaboration * Inspections and Audits support * Skilled in digital tools: compilation, regulatory database / information management, change control management, eCTD publishing and validation tools and e-submission portals