Umar Khan Email & Phone Number

India

• MOW NeeS/CTD/Paper Submissions - New Submissions and Lifecycle Maintenance activities.
• EU - LCM compilation and submissions through CESP, MHRA portals.

Hyderabad, Telangana, India

• RegOps-Publishing | Client: Sandoz
• MOW (APAC) Paper/CTD/NeeS/eCTD Submission Publishing - New Submissions and lifecycle maintenance activities - Renewals, Variations, DLs/HAQs, Safety Variations.
• Document-level Publishing (PDF formatting, Bookmarking).
• Preparing Registration status (m1) document as per templates and requirements for ROW countries.
• Creation of assembly and dossier outline, assigning documents to applicable modules and providing document attributes according to submission specific guidelines in publishing tool and attribute matrix.
• Generating PDF output and XML backbone.

Thane, Maharashtra, India

• Sr Associate-Document Specialist | Client: GSK
• Compliance checking and Primary publishing using appropriate tools - ISI Toolbox.
• Types of documents worked on: Protocols/Amendments, IBs, Annual Reports, CTA IMPDs, ICFs, CSRs as per client and regulatory specifications and requirements.
• Creating submission ready PDF documents by creating valid bookmarks and hyperlinks for electronic navigation and optimize the PDF files as per regulatory requirements.
• Reviewing and formatting Word and PDF documents as per client style guide to ensure they are error free and in compliance with specific templates and guidelines.
• Responsible for ensuring compliance to regulatory requirements and maintaining proper documentations, and associated documents are available within Electronic Document Management System (EDMS).