Global Pharma Submission Publishing

- Publish the regulatory submissions in eCTD, Nees, Paper format to different countries as per the individual HA requirements by using different publishing tools like eCTD Xpress and ISI Publisher etc.- Perform Internal quality and validation check, resolve the validation issues before sending it for line unit review- Ensure final document components are electronically archived according to the departmental practices in the document management system.

- Preparation and submission of regulatory dossiers for markets like US-FDA and EU such as: NDA,IND, BLA, MAA, PSUR and Promotional Labeling.- Perform submission publishing activities for the different regions with applicable dossier formats.Support regulatory submissions publishing Procedures like MRP, DCP, CP, National filingSubmissions.- Handing submissions in EU Market like variations (Initial, Response and closing sequence)Marketing Authorization Application, DMF.- Working on submission formats like: eCTD, NEES, Paper and Core Package.- Hands on experience in preparing assemblies, publishing, review of submissions and Life CycleManagement of eCTD submissions for US (US-FDA), Europe (EU), Australia (TGA), Switzerland(Swiss-medic), Gulf (GCC), Singapore (HSA).- Well versed at using publishing softwares such as Extedo and Docubridge for publishing regulatorysubmissions- Using validation tools like Lorenz E validator for validating submissions in order to check theauthenticity of a submission- Solving various validation errors received during publishing regulatory submissions

- Supported the development, review, approval and maintenance of Company Core Data Sheet (CCDS), USPI, and EU SmPC- Made updates to the generic labels in line with the innovator’s labels- Prepared and maintained CCDS logs containing a record of all changes made to each version of the CCDS- Created and updated SPL for submissions using label-bridge.- Utilized client end interface system (REEDTECH) to place orders for SPL conversion, review SPL using Docuproof before submission.- Provided editorial support to Global Labeling Leads (GLL) by reviewing labeling documents to ensure PLR compliance for US labels, QRD for EU labels and the current CDS template.- Reviewed artworks (Cartons, bottle labels, Inserts, Outserts, ECL etc).- Created and updated Cover letters, FDA form 356h and side by side comparison tables.- Updated labels in Health Authority prescribed formats – USPI to PLR (Physician’s Labelling Rule) and SPC to QRD (Quality Review of Document).- Uploaded and maintained track of label review stages; obtain approval of labeling documents in the Global Document Repository Tool.