Monika Mishra

Regulatory Affairs Associate

Parexel

01.2021 - Current

Worked on formatting, numbering, and styles and contents of a published document in accordance with client requirement to assure document is submission ready
Built eCTD Dossier for MRP, CP/DCP, NP for Europe using tools like Insight Publisher
Publishing activities (Compilation of Application as per Submission planner, Publishing of eCTD using Publishing tools (InSight Publisher)
Working knowledge in Europe, Nees, Australia, Thailand, Swiss, GCC submission
Experience on Lifecycle Submission based on client provided planners
Publishing of the complex regulatory document types (Word and PDF formatting, Bookmarking and Hyperlinking): CSR (Clinical Study Report), Protocol, Amendments, Statistical Analysis Plan, Investigator Brochures, IMPDs, Annual Reports, Case Report Forms, Non-Clinical Reports, Periodic Safety Report, PSUR and Risk Management Plan, Literature References
Compliance check report documents according to the client specific PDF guidelines.
Creation of assembly and dossier outline, assigning documents to applicable modules and rename the documents according to submission specific guidelines in publishing tool
Generating PDF output and XML backbone
Performs quality assurance of published output for completeness and correctness with respect to navigation and standard PDF attributes required for submission in regulatory agencies
Verify that final customer and/or agency deliverable meet all applicable regulatory standards
Document Level Publishing: Responsible for end-to-end document publishing and performing QA checks for Drug Safety Reports, Clinical and Non-Clinical Reports, SAP, NSR, Literature references Formatting of Annexes, Package Leaflets, SmPCs, and labeling Documents
Importing Task using e-CTD Manger, RIMs