Medical device consultation

Submission , approval, query response and post approval changes activities for EU market..*Regulatory Submision of DCP, national filing, Post Approval activities & Query response.*Reviewing Dossier compilation documents.*Well versed with e CTD dossier compilation.

Compilation and reviewing of regulatory dossiers in CTD / eCTD/ ACTD / Country specific format in submission for Brazil / Latam / MENA / South Korea and Hong Kong countries.Respond to queries on timely manner which are received from various regulatory agencies and customers.Review of technical documents like Pharmaceutical development report (PDR), batch manufacturing records, Process validation protocol and report, specification, analytical method validation protocol and report and stability reports for compliance with regulatory requirements.Preparation of strategy for development of generic version of innovator anticancer drugs.Liaison with various departments like F&D, Analytical Development, QC, QA, Production, CRO, stability departments.Handling of samples including preparation of relevant documents for regulatory submission / testing to various countries. Well-versed with various regulatory guidance for Brazil, Latam and South Korea submissions. Co-ordination with country regulatory counterparts for regulatory compliance during and after approval.Communicating with Global Marketing persons for dossier registration and to resolve the issue piled up during the process of registration and re-registration. Certificates Review of specification and Analytical procedures for raw materials, intermediates, packing materials, finished products and also respective certificates of analysis as per the requirements.Maintaining good coordination with all departments within the organization for smoother timely completion for the regulatory submissions/extend queries received.Coordination in applying various administrative registrations like drug licenses/manufacturing approvals, product permission, COPP etcFollow-up with manufacturing sites for the required data within the available timelines to reach the customer and/or marketing requirementsMaintenance of the database and submissions details and their status within the department

Dossier compilation for Brazil Market, Latam as per the Checklist.Responding to the authority Query and customer query on time.Liaison with various departments like F&D, Analytical Development, QC, QA, Production, CRO, stability departments.Handling of samples

Dossier compilation as per the checklist. Preparation of medical rational for the different drug products.Preparation of various reports including non-clinical and clinical usage report. Coordination with various departments like R&D, QC, QA, Production, CRO.