Shanker Battula

Experience

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  Mylan

  Aug 2013 - Aug 2016

  Regulatory Publishing Specialist

  Roles & Responsibilities: Regulatory Submissions, Publishing & Project Co-Ordination• Handling regulatory submissions like original applications, amendments, annual reports, supplements in eCTD format for various application types including NDA, ANDA and ANDS etc.• Preliminary Review of Documents (as per Regulatory eCTD standards), Build submissions, Compilation, QC Review (Quality Checking) of all Submissions. Compilation of new product registration application Dossier to US, CANADA and PEPFAR markets.• Sequential relationship building and monitoring the life cycle operations for submissions and variations for ANDA, NDA, ANDS, NDS. (USA, CA, PEPFAR markets).• Preparation of Side by Side labeling (Annotated Comparison Labeling) especially for PEPFAR market products and submissions.• Handling meetings, planning and execution of dossier submissions in respective of regulatory overview.• Ensuring all electronic standards in accordance with agency guidelines and ICH guidelines, Adhere to electronic standards as recommended by Agency and inline with company standards.• Submission Archiving once submitted to agency.• Planning, executing in meeting while responding eCTD queries/deficiencies to agency.• Accurate Bookmarking and Hyperlinking to PDF documents (manually and using tools).• Word to PDF rendering of documents.• Optimization of documents, creation of TOC, PDF scaling, Bookmarking, Hyperlinking (create/import/export), PDF version and other activities using ISI toolbox.• Performing Quality Checking (QC) on compiled output (ready submission).• Scrutinizing submission's PDF documents inline with PDF Specifications, company standards.Tools and Software's: Lorenz docuBridge, eCTD XPress, ISI Tool Box, Documentum Compliance Management (DCM)Adobe Acrobat 9 ProMS OfficeMS OutlookEver map Show less

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  Graviti Pharmaceuticals

  Sept 2016 - Nov 2017

  Regulatory Associate II - Regulatory Publishing Operations

  • Preparation and Compilation of eCTD Submissions for USA market.• Compilation of different type of submissions like Original application and other parts of application like IR, CR, CC, supplements, annual reports, etc.• Ensuring PDF standards that to be comply with ICH and FDA recommendations.• Creating bookmarks, hyperlinking (internal and external) accurately, TOC, Fast Web View and ensure other activities of eCTD submissions.• Delivering the submission using ESG (Electronic Submission Gateway) to FDA Divisions (like CDER, OC).• Submissions of Establishment Registration (Establishment Self Identification) using electronic format and their renewals annually.• Submissions of Labeller Code (NDC Labeller request) using electronic format.• Creation of SPL Label format.• Prepare label documents like Annotated comparison, Draft carton Container, Draft Labelling text etc.• Maintaining Records for ESG receipts, acknowledgment letters.• Handling of projects and maintain status to meet company’s timelines.• Perform QC (Quality Check) on compiled submissions.• Training and hands-on eCTD tools for team members.Tools and Software's: EduceDossier ManagementSPT (Submission Publishing Tool)Educe SPLAdobe Acrobat DC Show less

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  Ingenus Pharmaceuticals

  Nov 2017 - Mar 2020

  Executive - Regulatory Publishing and Labeling Operations
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  Freyr Solutions

  Apr 2020 - Jul 2023

  Team Lead-Software Solutions
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  Freyr Solutions

  Sept 2023 - now

  Assistant Manager - Regulatory Operations (TAKEDA)