Hithyshini Racharla

Regulatory Affairs at Regxia Inc.
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Contact Information
us****@****om
(386) 825-5501
Location
CA

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Credentials

  • Regulatory Affairs Certification (RAC)
    Regulatory Affairs Professionals Society (RAPS)
    Dec, 2021
    - Oct, 2024

Experience

  • Regxia Inc.
    • Canada
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs
      • Dec 2020 - Present

      • Responsible for compiling regulatory submissions to Health Canada and FDA including CTAs/INDs, NDSs/NDAs and ANDSs/ANDAs. • Preparation of gap analysis documents for ANDS, SANDS, NDS and lifecycle-management of the dossiers. • Preparation and submission of various types of submissions: NDS, ANDS, SNDS and administrative submissions to Health Canada • Preparation of responses to Clarifax, Screening Deficiency, Notice of Deficiency (NOD) and Notice of Non-compliance (NON) as appropriate and complete life-cycle management of diverse range of products. • Compilation of Module 2 summaries (CMC, non-clinical and clinical summaries) • Assessing and preparing necessary content for Module 1-5 in accordance with applicable guidance. • Prepare responses and post NOC changes to a drug product (life-cycle maintenance) for Health Canada and FDA (i.e. Clarifax, SDN, Amendments, etc.). • Compile, hyperlink, publish and validate submissions in eCTD format for Health Canada and FDA (DocuBridge) • Perform adverse drug reporting, prepare CIOMS form to submit an ADR report to Health Canada.

  • Cipla
    • India
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Assistant Manager, Regulatory Affairs
      • Aug 2016 - Jul 2020

      Regulatory Affairs - North America • Preparation and submission of regulatory documents for marketing authorization applications (original ANDA, amendments, supplements, annual reports, SPL/Drug listing to US Regulatory Authority (USFDA) • Regulatory manufacturing compliance activities including review of change controls (post approval changes), CMC documents, life-cycle maintenance of compliance documentation for regulatory approval. • Regulatory manufacturing compliance activities including review of change controls (post approval changes), CMC documents, life-cycle maintenance of compliance documentation for regulatory approval. • Launch activities including Gap Analysis and supporting Launch Business teams by providing regulatory inputs, as appropriate. • Providing Regulatory strategy, attending technical discussions with cross functional teams and review of documents required for CMC filing received from plant for its thoroughness. • Experience in drafting controlled correspondences, Pre submission of facility information (PFC), Competitive generic therapy submission and pre-ANDA meeting packages for complex drug products • Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.

  • Biological E. LTD
    • China
    • Senior Executive (AR&D)
      • Jul 2014 - Jul 2016

      • Wet Analysis including analysis of Samples by FT-IR and UV-Visible Spectrophotometer, KF-Auto titrator, Kjeldahl Apparatus and Particle Size Analyzer • Thermal Analysis: DSC and TGA • Development of analytical methods and method validations for Assay and Related Substances. (Empower3) • Analysis of samples by Waters HPLC (PDA and RI detectors) • Molecular weight determination by Gel permeation chromatography (waters and Shimadzu GPC software) • Calibration of instruments including HPLC, UV, IR, KF-Auto titrator, Melting Point Apparatus. • Transferring new analytical techniques to the Quality Control (QC) laboratory. • Undertaking any other duties, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood. • Analytical support and analytical problem solving to facilitate product development activities, including accelerated and long term stability testing and process development

  • Dr. Reddy's Laboratories
    • India
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Management Trainee
      • Aug 2013 - Jul 2014

      • Analysis of regular lab samples by LC-MS, FT-IR, HPLC and UV. • Identification of impurities by LC-MS and LC-MS/MS. • Training on NMR Instrumentation and theory. • Development of analytical methods and method validations for Assay and Related Substances (LC solutions). • Analysis of regular lab samples by LC-MS, FT-IR, HPLC and UV. • Identification of impurities by LC-MS and LC-MS/MS. • Training on NMR Instrumentation and theory. • Development of analytical methods and method validations for Assay and Related Substances (LC solutions).

Education

  • JNTU
    Master's degree, Pharmaceutical Sciences
    2012 - 2013
  • Rajiv Gandhi University of Health Sciences
    Bachelor's degree, Pharmacy
    2007 - 2011

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