Dev G

About Dev G

As a Regulatory Affairs Specialist at Implify, Inc, I leverage my expertise in…

Experience

1. Regulatory Affairs Specialist

   Implify, Inc.

   Nov 2019 — Present

   Expertise in assembling dossier plans for eCTD, non-eCTD electronic submissions, NeeS, ACTD, and paper-based formats. In-depth knowledge of regulatory submission requirements for eCTD format, hands-on experience in preparing, validating, and submitting documents in compliance with eCTD guidelines, as well as transmitting electronic submissions via the Electronic Submissions Gateway (ESG). Liaised between Regulatory Affairs and Publishing team to ensure submission-ready documents compliant with HA Submission Standards. Managed and coordinated IND/NDA filings to US FDA, ensuring timely approvals.• Experienced working on original application dossiers for IND, NDA 505 (b)(1) & 505 (b)(2), BLA, CTA, NDA, MAA, IMPD and necessary prior and post approval submissions to HA within a specified time frame. Responsible for the coordination and preparation of various Electronic Submissions for US FDA (eCTD Submissions) like NDA, BLA, IND, Annual reports,Periodic Safety reports (PAER, PSUR\'s), Supplements (CMC Supplements, Non clinical, Efficacy Supplements, and Labelling Supplements), Request for Information, Clinical Study Report (CSR\'s) using STF\'s and Node extensions. Led the preparation and submission of regulatory documents for commercial products, ensuring compliance with FDA and EMA regulations.Expertise in using Bookmark and Hyperlink tools in Virtual Link Manager in eCTDXpress and ISI Publisher.Experienced in publishing all 5 Modules in eCTD and CTD format and files of different format. Very Good knowledge of common errors and warnings for publishing and Validation tools. Experienced in submission and document level publishing documents by using Adobe, Word, ISI Toolbox, eCTD express, Validation, Peer reviewing documents in eCTD format. Compiled dossiers for Product correspondence activities like meeting requests, RTQs,briefing packages (TYPE A, B, and C) for Pre-IND, NDA meetings.Well-versed with Content management platforms like Livelink, Domasys, and Veeva Vault.